RECRUITING

HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM

Conditions

Glioblastoma Anaplastic Astrocytoma GBM, AA, Glioblastoma, Astrocytoma

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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

Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in newly diagnosed glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA).

Official Title

Phase I-II Study Evaluating HSV-tK + VALACYCLOVIR GENE THERAPY Combination with Radiotherapy and Chemotherapy for Newly Diagnosed Anaplastic Astrocytoma and Glioblastoma Multiforme.

Quick Facts

Study Start:2018-02-28

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03603405

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

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* All patients must have frozen section biopsy proven anaplastic astrocytoma or glioblastoma multiforme without evidence of multifocal disease defined as multiple lesions greater than 2 cm separate from the primary treatment target, or brainstem involvement as well as radiographic evidence consistent with these diagnoses. * Life expectancy ≥ 12 weeks. * Patients should have the following characteristics: newly diagnosed anaplastic astrocytoma or glioblastoma demonstrated by frozen section biopsy, prior surgery which demonstrated anaplastic astrocytoma or glioblastoma multiforme which requires repeat surgery for residual tumor, but no radiation or chemotherapy has been received, ECOG performance status of 0-1. No evidence of other active malignancy (except squamous or basal cell skin cancers). * Patients with leptomeningeal disease may be considered for enrollment into the study. * Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks of the study by the investigator (or his/her designee) with the aid of written information. * Willing to provide biopsies as required by the study. * WOCBP must have a negative serum pregnancy test within 7 days prior to the administration of the first study treatment. Women must not be lactating. * WOCBP and men must practice an effective method of birth control * Patients must have adequate baseline organ function as assessed by the following laboratory values before initiating the protocol: * serum creatinine \< 1.5 mg/dL * T. bilirubin \< 2.5 mg/dL, ALT, AST, GGT and Alk Phos \< 2 x normal * Platelet count \> 100,000/ml , ANC\> 1500/ml , Hgb\> 10 gm/dL * Normal partial thromboplastin time (PTT) and Pro-Thrombin Time (PT)	* Prior treatment with immunomodulatory therapy, immunotherapy, and/or gene vector therapy in the past 3 months. * Any cytotoxic chemotherapy, RT, or immunotherapy or any investigational drug within 3 weeks of study treatment start. * Evidence of substantial multifocal disease defined as multiple lesions greater than 2cm separate from the primary treatment target, or brainstem involvement. Discrete areas of contrast enhancement connected by abnormal T2 FLAIR signal on MRI scan are not considered multifocal disease, as this represents a single tumor. * Patients with brainstem involvement, in patients with leptomeningeal disease, no evidence of diffuse disease or spread to the spine. * Patients on immunosuppressive drugs (other than steroids for brain edema). * In patients with leptomeningeal disease, no evidence of diffuse disease or spread to the spine. * In patients with leptomeningeal disease, no bulky leptomeningeal metastases with potential to obstruct CSF flow will not be enrolled. * Liver disease, such as cirrhosis or active/chronic hepatitis B or C. * History of or current alcohol misuse/abuse within the past 12 months. * Known or suspected allergy or hypersensitivity to any component of the proposed regimen (gene vector/Valacyclovir). * Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications (Valacyclovir). * No active malignancy except for non-melanoma skin cancer or in situ cervical cancer or treated cancer from which the patient has been continuously disease free for more than 3 years. * The presence of active CNS toxoplasmosis infection or Progressive Multifocal Leukoencephalopathy demonstrated on CT or MRI imaging * The presence of active untreated cellulitis or untreated wound infections. Treated and resolving cellulitis and infections are not an exclusion criteria. * Active IV drug abuse or severe opioid abuse * Pregnant or breastfeeding women or women/men able to conceive and unwilling to practice an effective method of birth control. WOCBP must have a negative serum pregnancy test within 7 days prior to the administration of the first study treatment. * Presence of active or suspected acute or chronic uncontrolled infection or history of immunocompromise, including a positive HIV test result. * Patients \< 18 years of age * Unwilling or unable to comply with the study protocol.

Inclusion Criteria

Exclusion Criteria

* All patients must have frozen section biopsy proven anaplastic astrocytoma or glioblastoma multiforme without evidence of multifocal disease defined as multiple lesions greater than 2 cm separate from the primary treatment target, or brainstem involvement as well as radiographic evidence consistent with these diagnoses.
* Life expectancy ≥ 12 weeks.
* Patients should have the following characteristics: newly diagnosed anaplastic astrocytoma or glioblastoma demonstrated by frozen section biopsy, prior surgery which demonstrated anaplastic astrocytoma or glioblastoma multiforme which requires repeat surgery for residual tumor, but no radiation or chemotherapy has been received, ECOG performance status of 0-1. No evidence of other active malignancy (except squamous or basal cell skin cancers).
* Patients with leptomeningeal disease may be considered for enrollment into the study.
* Signed informed consent to participate in the study must be obtained from patients after they have been fully informed of the nature and potential risks of the study by the investigator (or his/her designee) with the aid of written information.
* Willing to provide biopsies as required by the study.
* WOCBP must have a negative serum pregnancy test within 7 days prior to the administration of the first study treatment. Women must not be lactating.
* WOCBP and men must practice an effective method of birth control
* Patients must have adequate baseline organ function as assessed by the following laboratory values before initiating the protocol:
* serum creatinine \< 1.5 mg/dL
* T. bilirubin \< 2.5 mg/dL, ALT, AST, GGT and Alk Phos \< 2 x normal
* Platelet count \> 100,000/ml , ANC\> 1500/ml , Hgb\> 10 gm/dL
* Normal partial thromboplastin time (PTT) and Pro-Thrombin Time (PT)

* Prior treatment with immunomodulatory therapy, immunotherapy, and/or gene vector therapy in the past 3 months.
* Any cytotoxic chemotherapy, RT, or immunotherapy or any investigational drug within 3 weeks of study treatment start.
* Evidence of substantial multifocal disease defined as multiple lesions greater than 2cm separate from the primary treatment target, or brainstem involvement. Discrete areas of contrast enhancement connected by abnormal T2 FLAIR signal on MRI scan are not considered multifocal disease, as this represents a single tumor.
* Patients with brainstem involvement, in patients with leptomeningeal disease, no evidence of diffuse disease or spread to the spine.
* Patients on immunosuppressive drugs (other than steroids for brain edema).
* In patients with leptomeningeal disease, no evidence of diffuse disease or spread to the spine.
* In patients with leptomeningeal disease, no bulky leptomeningeal metastases with potential to obstruct CSF flow will not be enrolled.
* Liver disease, such as cirrhosis or active/chronic hepatitis B or C.
* History of or current alcohol misuse/abuse within the past 12 months.
* Known or suspected allergy or hypersensitivity to any component of the proposed regimen (gene vector/Valacyclovir).
* Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications (Valacyclovir).
* No active malignancy except for non-melanoma skin cancer or in situ cervical cancer or treated cancer from which the patient has been continuously disease free for more than 3 years.
* The presence of active CNS toxoplasmosis infection or Progressive Multifocal Leukoencephalopathy demonstrated on CT or MRI imaging
* The presence of active untreated cellulitis or untreated wound infections. Treated and resolving cellulitis and infections are not an exclusion criteria.
* Active IV drug abuse or severe opioid abuse
* Pregnant or breastfeeding women or women/men able to conceive and unwilling to practice an effective method of birth control. WOCBP must have a negative serum pregnancy test within 7 days prior to the administration of the first study treatment.
* Presence of active or suspected acute or chronic uncontrolled infection or history of immunocompromise, including a positive HIV test result.
* Patients \< 18 years of age
* Unwilling or unable to comply with the study protocol.

Contacts and Locations

Study Contact

David S. Baskin, MD

CONTACT

713-441-3803 or 713-201-5792

DBaskin@houstonmethodist.org

Helga M. Jones

CONTACT

713-363-9388

HMJones@houstonmethodist.org

Principal Investigator

David S. Baskin, MD

PRINCIPAL_INVESTIGATOR

Houston Methodist Neurological Institute

Study Locations (Sites)

Houston Methodist Neurological Institute

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: The Methodist Hospital Research Institute

David S. Baskin, MD, PRINCIPAL_INVESTIGATOR, Houston Methodist Neurological Institute

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 Date2018-02-28

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2018-02-28

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

GBM, AA, Glioblastoma, Astrocytoma

Additional Relevant MeSH Terms

Glioblastoma
Anaplastic Astrocytoma