HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM

STATUS

Recruiting
End date

Dec 30, 2025
participants needed

62
sponsor

David Baskin MD

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Updated on 6 September 2023

See if I qualify

platelet count

cancer

MRI

flair

aptt

glioblastoma multiforme

astrocytoma

recurrent glioblastoma

anaplastic astrocytoma

astrocytoma, anaplastic

valacyclovir

Summary

Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in recurrent glioblastoma multiforme.

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 in recurrent glioblastoma multiforme or anaplastic astrocytoma. This study is comprised of patients who have failed standard of care treatment (maximal safe resection followed by chemoradiation).

Clinical response will be evaluated by neurological evaluation, neuropsychological testing, and imaging studies as well as by histological examination wherever a re-operation is clinically indicated. Blood samples will be taken for systemic immunological response, blood counts and liver functions tests. Toxicity will be graded by the Common Terminology Criteria for Adverse Events (CTCAE) and Radiation Therapy Oncology Group (RTOG) neuro-toxicity scores. Patients will also be followed to assess median time to progression and median survival.

Details

Condition	Glioblastoma Multiforme, Astrocytoma, Grade III
Treatment	ADV/HSV-tk (gene therapy)
Clinical Study Identifier	NCT03596086
Sponsor	David Baskin MD
Last Modified on	6 September 2023

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	All patients must have biopsy proven recurrent anaplastic astrocytoma or glioblastoma multiforme without evidence of multifocal tumor or brainstem involvement. Multifocal disease does not exist if enhancing areas are connected by abnormal T2 FLAIR on the MRI scan
	Radiographic evidence of recurrence/progression by iRANO criteria
	≥ 3 weeks since any major surgery, completion of RT, or completion of all prior systemic anticancer therapy (adequately recovered from the acute toxicities of any prior therapy)
	Life expectancy ≥ 12 weeks
	Patient can receive second treatment of HSV-tk after 6 months
	Patients should have the following characteristics: recurrent glioblastoma or AA demonstrated by biopsy or imaging study, ECOG performance status of 0-1, has had prior surgery and radiotherapy /chemotherapy for the glioblastoma
	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 AP < 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)
	Non English speaking patients can participate in this study
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 for this brain tumor within 3 weeks of study treatment start
	Patients on immunosuppressive drugs (other than steroids for brain edema)
	Evidence of multifocal disease, brainstem involvement
	Liver disease, such as cirrhosis or active/chronic hepatitis B or C
	History of or current alcohol misuse/abuse within the past 12 months
	In patients with leptomeningeal disease, no evidence of diffuse disease or spread to the spine
	Known or suspected allergy or hypersensitivity to any component of the proposed regimen (gene vector-HSV-tk, Valacyclovir)
	In patients with leptomeningeal disease, no bulky leptomeningeal metastases with potential to obstruct CSF flow will not be enrolled
	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 5 years
	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
	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

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Study Definition

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HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM