HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM

STATUS

Recruiting
End date

Dec 31, 2025
participants needed

62
sponsor

The Methodist Hospital Research Institute

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Updated on 3 September 2023

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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 Identifier	NCT03603405
Sponsor	The Methodist Hospital Research Institute
Last Modified on	3 September 2023

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Eligibility		Yes	No	Not Sure
Inclusion 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
	Patient can receive second treatment of HSV-tk after 6 months
	Patients should have the following characteristics: newly diagnosed anaplastic
	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
	astrocytoma or glioblastoma demonstrated by frozen section biopsy, prior
	surgery which demonstrated anaplastic astrocytoma or glioblastoma multiforme
	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
	which requires repeat surgery for residual tumor, but no radiation or
	WOCBP and men must practice an effective method of birth control
	chemotherapy has been received, ECOG performance status of 0-1. No evidence of
	Patients must have adequate baseline organ function as assessed by the following laboratory values before initiating the protocol
	other active malignancy (except squamous or basal cell skin cancers)
	serum creatinine < 1.5 mg/dL
	Patients with leptomeningeal disease may be considered for enrollment into the study
	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
	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
	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
	The presence of active CNS toxoplasmosis infection or Progressive Multifocal Leukoencephalopathy demonstrated on CT or MRI imaging
	Patients with brainstem involvement, in patients with leptomeningeal disease, no evidence of diffuse disease or spread to the spine
	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
	In patients with leptomeningeal disease, no evidence of diffuse disease or spread to the spine
	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
	In patients with leptomeningeal disease, no bulky leptomeningeal metastases with potential to obstruct CSF flow will not be enrolled
	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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HSV-tk and XRT and Chemotherapy for Newly Diagnosed GBM