RECRUITING

Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel

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Conditions

NeoplasmsPharmacodynamicBCR Abl kinase inhibitorTaxanesCombination

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Background: People with rare cancers often have limited treatment options. The biology of rare cancers is not well understood. Researchers want to find better treatments for these cancers. They want to test 2 drugs that, taken separately, have helped people with non-rare cancers. They want to see if these drugs together can make rare cancers shrink or stop growing. Objective: To learn if nilotinib and paclitaxel will benefit people with rare cancers. Eligibility: People age 18 and older who have a rare, advanced cancer that has progressed after receiving standard treatment, or for which no effective therapy exists. Design: Participants will be screened with medical history and physical exam. They will have blood and urine tests. They will have a pregnancy test if needed. They will have an electrocardiogram to check their heart. They will have imaging scans to measure their tumors. Participants will repeat the screening tests during the study. Participants will receive nilotinib and paclitaxel. The drugs are given in 28-day cycles. Nilotinib is a capsule taken by mouth twice a day. Paclitaxel will be given intravenously by peripheral line or central line once a week for the first 3 weeks of each cycle. Participants will keep a medicine diary. They will track when they take the study drugs and any side effects they may have. Participants may have optional tumor biopsies. Participants can stay on the study until their disease gets worse or they have intolerable side effects. Participants will have a follow-up phone call about 30 days after taking the last dose of study drugs....

Official Title

Rapid Analysis and Response Evaluation of Combination Anti-Neoplastic Agents in Rare Tumors (RARE CANCER) Trial: RARE 1 Nilotinib and Paclitaxel

Quick Facts

Study Start:2020-08-24
Study Completion:2026-04-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04449549

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must have histologically confirmed rare solid tumors that have progressed on standard therapy known to prolong survival or for which no standard treatment options exist. The list of eligible rare tumors can be found below\*\*. With Amendment G (v 6-17-24), eligibility will be limited to patients with adult granulosa cell ovarian cancer, clear cell ovarian cancer, anal cancer, or Ewing sarcoma.Patients must have measurable and evaluable disease.
  2. * Age \>= 18 years.
  3. * ECOG performance status \<= 2.
  4. * Patients must have normal organ and marrow function as defined below:
  5. * Absolute neutrophil count \>=1,500/mcL
  6. * Platelets \>=100,000/mcL
  7. * Total bilirubin \<=1.5 X institutional ULN
  8. * AST(SGOT)/ALT(SGPT) \<=3 X institutional upper limit of normal; \<= 5.0 x ULN in patients with liver metastases
  9. * creatinine \<=1.5 X institutional ULN OR
  10. * creatinine clearance \>=60 mL/min/1.73 m\^2 for patients with creatinine levels \>1.5 mg/dL
  11. * Nilotinib and paclitaxel have both been assigned to pregnancy category D by the FDA. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for at least 3 months after dosing with study drugs ceases. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of study drug administration.
  12. * Patients must have completed radiation therapy or major surgery \>= 3 weeks, or biologic therapy or chemotherapy \>= 5 half-lives or 3 weeks, whichever is shorter (6 weeks for nitrosoureas and mitomycin C) prior to entering the study. Patients must be \>= 2 weeks since any prior administration of a study drug in a Phase 0 or equivalent study and be \>= 1 week from palliative radiation therapy (patients on study may be eligible for palliative radiotherapy to non-targeted lesions after 2 cycles of therapy at the PI s discretion). Patients must have recovered to eligibility levels from prior toxicity or adverse events. Treatment with bisphosphonates is permitted.
  13. * Biopsies are optional on this study. In lieu of baseline biopsies, patients are encouraged to submit at registration archival tumor biopsy tissue from a previous research study or medical care providing it meets the minimum collection and preservations requirements outlined for the submission of archival tissue are:
  14. * Tissue must have been collected within 3 months prior to registration.
  15. * Patient must not have received any intervening therapy for their cancer since the collection of the tumor sample.
  16. * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. For these patients, an HIV viral load test must be completed within 28 days prior to enrollment.
  17. * Rare Tumor Eligibility List
  18. 1. Epithelial tumors of nasal cavity, sinuses, nasopharynx
  19. 2. Epithelial tumors of major salivary glands
  20. 3. Salivary gland type tumors of head and neck, lip, esophagus, stomach, trachea and lung, breast and other location
  21. 4. Undifferentiated carcinoma of gastrointestinal (GI) tract
  22. 5. Adenocarcinoma with variants of small intestine
  23. 6. Squamous cell carcinoma with variants of GI tract (stomach small intestine, colon, rectum, pancreas)
  24. 7. Fibromixoma and low-grade mucinous adenocarcinoma (pseudomixoma peritonei) of the appendix and ovary
  25. 8. Rare Pancreatic tumors including acinar cell carcinoma, mucinous cystadenocarcinoma or serous cystadenocarcinoma
  26. 9. Intrahepatic cholangiocarcinoma
  27. 10. Extrahepatic cholangiocarcinoma and bile duct tumors
  28. 11. Sarcomatoid carcinoma of lung
  29. 12. Bronchoalveolar carcinoma lung (a.k.a. adenocarcinoma in situ, minimally invasive adenocarcinoma, lepidic predominant adenocarcinoma, or invasive mucinous adenocarcinoma)
  30. 13. Non-epithelial tumors of the ovary
  31. 14. Trophoblastic tumor
  32. 15. Transitional cell carcinoma other than that of the renal, pelvis, ureter, or bladder
  33. 16. Cell tumor of the testes and extragonadal germ tumors
  34. 17. Epithelial tumors of penis - squamous adenocarcinoma cell carcinoma with variants of penis
  35. 18. Squamous cell carcinoma variants of the genitourinary (GU) system
  36. 19. Spindle cell carcinoma of kidney, pelvis, ureter
  37. 20. Adenocarcinoma with variants of GU system (excluding prostate cancer)
  38. 21. Odontogenic malignant tumors
  39. 22. Pancreatic neuroendocrine tumor (PNET)
  40. 23. Neuroendocrine carcinoma including carcinoid of the lung
  41. 24. Pheochromocytoma, malignant
  42. 25. Paraganglioma
  43. 26. Carcinomas of pituitary gland, thyroid gland parathyroid gland and adrenal cortex
  44. 27. Desmoid tumors
  45. 28. Peripheral nerve sheath tumors and NF1-related tumors
  46. 29. Malignant giant cell tumors
  47. 30. Chordoma
  48. 31. Adrenal cortical tumors
  49. 32. Tumor of unknown primary (Cancer of Unknown Primary; CuP)
  50. 33. Not Otherwise Categorized (NOC) Rare Tumors
  51. 34. Adenoid cystic carcinoma
  52. 35. Vulvar cancer
  53. 36. MetaPLASTIC carcinoma (of the breast)
  54. 37. Gastrointestinal stromal tumor (GIST)
  55. 38. Perivascular epithelioid cell tumor (PEComa)
  56. 39. Apocrine tumors/Extramammary Paget s Disease
  57. 40. Peritoneal mesothelioma
  58. 41. Basal cell carcinoma
  59. 42. Clear cell cervical cancer
  60. 43. Esthenioneuroblastoma
  61. 44. Endometrial carcinosarcoma (malignant mixed Mullerian tumors)
  62. 45. Clear cell endometrial cancer
  63. 46. Clear cell ovarian cancer
  64. 47. Gestational trophoblastic disease (GTD)
  65. 48. Gallbladder cancer
  66. 49. Small cell carcinoma of the ovary, hypercalcemic type
  67. 50. Angiosarcoma
  68. 51. High-grade neuroendocrine carcinoma
  69. 52. Treatment-emergent small-cell neuroendocrine prostate cancer (t-SCNC)
  70. 53. Anal cancer
  71. 54. Lymphoma
  72. 55. Merkel cell carcinoma
  73. 56. Pleural Mesothelioma
  74. 57. Sarcoma (bone \& soft tissue)
  75. 58. Thymic Carcinoma
  76. 59. Uterine Leiomyosarcoma
  77. 60. Papillary RCC
  1. * QTcF interval of \>=450 msec at study entry; congenital long QT syndrome
  2. * Sensory/motor neuropathy \>= Grade 2
  3. * Patients who are receiving any other investigational agents.
  4. * Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:
  5. * Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:
  6. * Evaluable or measurable disease outside the CNS
  7. * No metastases to brain stem, midbrain, pons, medulla, or cerebellum
  8. * No history of intracranial hemorrhage or spinal cord hemorrhage
  9. * No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted.
  10. * No neurosurgical resection or brain biopsy within 28 days prior to Cycle 1, Day 1
  11. * Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:
  12. * Radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and radiographic screening for the current study
  13. * No stereotactic radiation or whole-brain radiation within 28 days prior to Cycle 1, Day 1
  14. * Screening CNS radiographic study \>=4 weeks from completion of radiotherapy and \>=2 weeks from discontinuation of corticosteroids
  15. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs.
  16. * Uncontrolled intercurrent illness including, but not limited to, serious untreated infection, symptomatic respiratory failure/congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  17. * Pregnant women are excluded from this study because nilotinib and paclitaxel have been assigned to pregnancy category D by the FDA. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with the study drugs, breastfeeding should be discontinued prior to the first dose of study drug and women should refrain from nursing throughout the treatment period and for 3 months following the last dose of study drug.

Contacts and Locations

Study Contact

Brooksley F Augustine
CONTACT
(240) 858-3197
brooke.augustine@nih.gov
Alice P Chen, M.D.
CONTACT
(240) 781-3320
chenali@mail.nih.gov

Principal Investigator

Alice P Chen, M.D.
PRINCIPAL_INVESTIGATOR
National Cancer Institute (NCI)

Study Locations (Sites)

National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Alice P Chen, M.D., PRINCIPAL_INVESTIGATOR, National Cancer Institute (NCI)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-24
Study Completion Date2026-04-08

Study Record Updates

Study Start Date2020-08-24
Study Completion Date2026-04-08

Terms related to this study

Keywords Provided by Researchers

  • Pharmacodynamic
  • BCR Abl kinase inhibitor
  • Taxanes
  • Combination

Additional Relevant MeSH Terms

  • Neoplasms