HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    62
  • sponsor
    The Methodist Hospital System
Updated on 5 March 2022
platelet count
cancer
aptt
glioblastoma multiforme
astrocytoma
anaplastic astrocytoma
astrocytoma, anaplastic
valacyclovir

Summary

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).

Description

This is a prospective, phase I-II study to assess the efficacy and toxicity of HSV-tk + valacyclovir gene therapy in combination with radiotherapy and standard of care chemotherapy for anaplastic astrocytoma (AA) or glioblastoma multiforme (GBM). This study is comprised of newly diagnosed patients with AA or GBM.

Clinical response will be evaluated by neurological evaluation, neuropsychological testing, and imaging studies as well as by histological examination. Blood samples will be taken for systemic immunological response, blood counts, and liver functions tests. Genetic testing of tumor tissue will be performed, including genetic analysis and cell cultures. Toxicity will be graded by the Common Terminology Criteria for Adverse Events (CTCAE) v4.03 and Radiation Therapy Oncology Group (RTOG) neuro-toxicity scores (see Appendices). Patients will also be followed to assess median time to progression and median survival.

Details
Condition Glioblastoma, Anaplastic Astrocytoma
Treatment ADV/HSV-tk (gene therapy)
Clinical Study IdentifierNCT03603405
SponsorThe Methodist Hospital System
Last Modified on5 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

All patients must have frozen section biopsy proven anaplastic astrocytoma or glioblastoma multiforme without evidence of multifocal tumor or leptomeningeal metastatic disease or brainstem involvement as well as radiographic evidence consistent with these diagnoses
Life expectancy 12 weeks
Patient can receive second treatment of HSV-tk after 6 months
Patients should have the following characteristics: newly diagnosed anaplastic astrocytoma or glioblastoma demonstrated by frozen section biopsy, ECOG performance status of 0-1. No evidence of other active malignancy (except squamous or basal cell skin cancers)
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)

Exclusion Criteria

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 multifocal disease, brainstem involvement, or leptomeningeal metastasis, 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 on immunosuppressive drugs (other than steroids for brain edema)
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
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