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New treatment option for Glioblastoma Multiforme
Official title HSV-tk + Valacyclovir + SBRT + Chemotherapy for Recurrent GBM
ClinicalTrials.gov ID: NCT03596086
What this study is testing
What is ADV/HSV-tk (gene therapy)?
ADV/HSV-tk (gene therapy) is an investigational medicine, being studied as a potential treatment for glioblastoma multiforme.
Also referred to as gene transfer, gene therapy, HSV-tk.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Study to assess the safety and efficacy of HSV-tk (gene therapy), valacyclovir, radiotherapy and chemotherapy in recurrent glioblastoma multiforme.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- All patients must have biopsy proven recurrent anaplastic astrocytoma or glioblastoma multiforme without evidence of multifocal tumor or brainstem...
- 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...
- Life expectancy ≥ 12 weeks.
- Patient can receive second treatment of HSV-tk after 6 months
You likely can't join if
- 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.
- Evidence of multifocal disease, brainstem involvement
- 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.
See the full eligibility 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...
- 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...
- Patients with leptomeningeal disease may be considered for enrollment into the study.
- 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...
- 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
- 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.
- Evidence of multifocal disease, brainstem involvement
- 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-HSV-tk, 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 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.