RECRUITING

Vorinostat in Combination With Chemotherapy in Relapsed/Refractory Solid Tumors and CNS Malignancies

Conditions

Ewing Sarcoma Rhabdomyosarcoma Wilms Tumor Neuroblastoma Hepatoblastoma Germ Cell Tumor

Quick Navigation

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

Investigators are testing new experimental drug combinations such as the combination of vorinostat, vincristine, irinotecan, and temozolomide in the hopes of finding a drug that may be effective against tumors that have come back or that have not responded to standard therapy. The goals of this study are: * To find the highest safe dose of vorinostat that can be given together with vincristine, irinotecan, and temozolomide without causing severe side effects; * To learn what kind of side effects this four drug combination can cause; * To learn about the effects of vorinostat and the combination of vorinostat, vincristine, irinotecan, and temozolomide on specific molecules in tumor cells; * To determine whether the combination of vorinosat, vincristine, irinotecan, and temozolomide is a beneficial treatment.

Official Title

A Phase I Study of Vorinostat in Combination With Vincristine, Irinotecan, and Temozolomide in Children, Adolescents, and Young Adults With Relapsed or Refractory Solid Tumors and CNS Malignancies

Quick Facts

Study Start:2017-03-17

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04308330

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:1 Year to 30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
* Age: Patients must be less than or equal to 1 year and less than or equal to 30 years of age at initiation of protocol therapy. * Diagnosis: Patients must have a confirmed histologic diagnosis of a relapsed or refractory solid tumor or CNS malignancy. * Performance status: Patients over 16 years of age must have a Karnofsky score greater than or equal to 50. Children under 16 years of age must have a Lansky score greater than or equal to 50. * Prior therapy: Patients may have received prior therapy with vincristine, irinotecan, or temozolomide. They may not however have received therapy that included a treatment cassette of irinotecan and temozolomide in combination. * Prior myelosuppressive therapy: Patients must have not received myelosuppressive therapy in 3 weeks or nitrosourea chemotherapy within 6 weeks of initiation of protocol therapy. * Hematologic growth factor support: Patients may not have received G-CSF within the previous 3 days or peg-filgrastim within the past 7 days. * Biologic anti-neoplastic therapy: At least 21 days or 5 half-lives (whichever is of longer duration) must have elapsed since the last administration of biologic antineoplastic therapy. * Radiation therapy: ≥ 14 days since the last dose of local XRT; ≥ 6 months must have elapsed if prior TBI, craniospinal XRT or ≥ 50% radiation of pelvis; ≥ 6 wks must have elapsed if other substantial BM radiation. * Autologous or allogeneic stem cell transplant: No active graft vs. host disease or need for immunosuppressive therapy. At least 3 months must have passed since neutrophil engraftment. * Organ function: * Peripheral absolute neutrophil count (ANC) greater than or equal to 1000 cells/mcL. * Platelet count greater than or equal to100,000/mcL and no platelet transfusion within prior 7 days. * Hemoglobin greater than or equal to 8 gm/dL * Patients with known bone marrow metastatic disease may enroll on the study if they have a peripheral ANC greater than or equal to 750 cells/mcL. They will not be evaluable for hematologic toxicity. * Total bilirubin less than or equal to 1.5x upper limit of normal (ULN) for age. * SGPT (ALT) less than or equal to 5x ULN * Serum albumin greater than or equal to 2 gm/dL * Creatinine clearance or glomerular filtration rate \>70 ml/min/1.73 m2 or a serum creatinine based on age and gender as follows:	* Pregnancy or breast feeding: Women who are pregnant or breast feeding will not be entered on the protocol due to the risks of fetal and teratogenic adverse events with the therapeutic agents used in the protocol therapy. * Corticosteroid use: Patients with CNS tumors who have not been on a stable or decreasing dose of corticosteroids for the 7 days prior to the initiation of protocol therapy. * Antineoplastic therapy: Patients receiving any other antineoplastic therapy. * Medication allergy: * Infection: Patients who have any uncontrolled infection, positive blood culture within 48 hours prior to protocol entry, or diagnosed or receiving therapy for Clostridium difficile infection. * Patients may not have taken valproic acid or any other histone deacetylase inhibitor for at least 2 weeks prior to study enrollment. * Children with neurofibromastosis Type 1, if being used for treatment of a low grade glioma.

Inclusion Criteria

Exclusion Criteria

* Age: Patients must be less than or equal to 1 year and less than or equal to 30 years of age at initiation of protocol therapy.
* Diagnosis: Patients must have a confirmed histologic diagnosis of a relapsed or refractory solid tumor or CNS malignancy.
* Performance status: Patients over 16 years of age must have a Karnofsky score greater than or equal to 50. Children under 16 years of age must have a Lansky score greater than or equal to 50.
* Prior therapy: Patients may have received prior therapy with vincristine, irinotecan, or temozolomide. They may not however have received therapy that included a treatment cassette of irinotecan and temozolomide in combination.
* Prior myelosuppressive therapy: Patients must have not received myelosuppressive therapy in 3 weeks or nitrosourea chemotherapy within 6 weeks of initiation of protocol therapy.
* Hematologic growth factor support: Patients may not have received G-CSF within the previous 3 days or peg-filgrastim within the past 7 days.
* Biologic anti-neoplastic therapy: At least 21 days or 5 half-lives (whichever is of longer duration) must have elapsed since the last administration of biologic antineoplastic therapy.
* Radiation therapy: ≥ 14 days since the last dose of local XRT; ≥ 6 months must have elapsed if prior TBI, craniospinal XRT or ≥ 50% radiation of pelvis; ≥ 6 wks must have elapsed if other substantial BM radiation.
* Autologous or allogeneic stem cell transplant: No active graft vs. host disease or need for immunosuppressive therapy. At least 3 months must have passed since neutrophil engraftment.
* Organ function:
* Peripheral absolute neutrophil count (ANC) greater than or equal to 1000 cells/mcL.
* Platelet count greater than or equal to100,000/mcL and no platelet transfusion within prior 7 days.
* Hemoglobin greater than or equal to 8 gm/dL
* Patients with known bone marrow metastatic disease may enroll on the study if they have a peripheral ANC greater than or equal to 750 cells/mcL. They will not be evaluable for hematologic toxicity.
* Total bilirubin less than or equal to 1.5x upper limit of normal (ULN) for age.
* SGPT (ALT) less than or equal to 5x ULN
* Serum albumin greater than or equal to 2 gm/dL
* Creatinine clearance or glomerular filtration rate \>70 ml/min/1.73 m2 or a serum creatinine based on age and gender as follows:

* Pregnancy or breast feeding: Women who are pregnant or breast feeding will not be entered on the protocol due to the risks of fetal and teratogenic adverse events with the therapeutic agents used in the protocol therapy.
* Corticosteroid use: Patients with CNS tumors who have not been on a stable or decreasing dose of corticosteroids for the 7 days prior to the initiation of protocol therapy.
* Antineoplastic therapy: Patients receiving any other antineoplastic therapy.
* Medication allergy:
* Infection: Patients who have any uncontrolled infection, positive blood culture within 48 hours prior to protocol entry, or diagnosed or receiving therapy for Clostridium difficile infection.
* Patients may not have taken valproic acid or any other histone deacetylase inhibitor for at least 2 weeks prior to study enrollment.
* Children with neurofibromastosis Type 1, if being used for treatment of a low grade glioma.

Contacts and Locations

Study Contact

Harshini Mahanti, BS

CONTACT

914-594-2143

harshini_mahanti@nymc.edu

Lauren Harrison, MSN

CONTACT

617-285-7844

lauren_harrison@nymc.edu

Principal Investigator

Jeremy Rosenblum, MD

PRINCIPAL_INVESTIGATOR

New York Medical College

Study Locations (Sites)

New York Medical College

Valhalla, New York, 10595

United States

Collaborators and Investigators

Sponsor: New York Medical College

Jeremy Rosenblum, MD, PRINCIPAL_INVESTIGATOR, New York Medical College

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 Date2017-03-17

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2017-03-17

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Ewing Sarcoma
Rhabdomyosarcoma
Wilms Tumor
Neuroblastoma
Hepatoblastoma
Germ Cell Tumor