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Biological Therapy and Radiation Therapy in Treating Patients With Newly Diagnosed Glioblastoma Multiforme

Study Purpose

RATIONALE: Biological therapies such as poly-ICLC use different ways to stimulate the immune system and stop tumor cells from growing. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining biological therapy with radiation therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining poly-ICLC with radiation therapy in treating patients who have newly diagnosed glioblastoma multiforme.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - Histologically confirmed intracranial glioblastoma multiforme (GBM) or gliosarcoma by biopsy or resection within the past 28 days.
PATIENT CHARACTERISTICS: Age.
  • - 18 and over.
Performance status.
  • - Karnofsky 60-100% Life expectancy.
  • - More than 8 weeks.
Hematopoietic.
  • - WBC at least 3,000/mm^3.
  • - Absolute neutrophil count at least 1,500/mm^3.
  • - Platelet count at least 100,000/mm^3.
  • - Hemoglobin at least 10 g/dL (transfusion allowed) Hepatic.
  • - Bilirubin less than 2 times upper limit of normal (ULN) - SGOT less than 2 times ULN.
Renal.
  • - Creatinine less than 1.5 mg/dL.
Other.
  • - No significant medical illness that cannot be controlled adequately with appropriate therapy or that would compromise tolerability of study therapy.
  • - No other cancer (except nonmelanoma skin cancer or carcinoma in situ of the cervix) unless in complete remission and off all therapy for that disease for at least 3 years.
  • - No active infection.
  • - No disease that would obscure toxicity or dangerously alter drug metabolism.
  • - No other serious concurrent medical illness.
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use effective contraception.
PRIOR CONCURRENT THERAPY: Biologic therapy.
  • - Not specified.
Chemotherapy.
  • - No prior polifeprosan 20 with carmustine implant (Gliadel wafer) - No concurrent chemotherapy.
Endocrine therapy.
  • - Concurrent corticosteroids to treat symptoms or prevent complications are allowed.
Radiotherapy.
  • - No prior radiotherapy to the brain.
  • - No concurrent stereotactic radiosurgery.
  • - No concurrent brachytherapy.
Surgery.
  • - See Disease Characteristics.
Other.
  • - No prior cytotoxic or noncytotoxic drug therapy for GBM.
  • - No prior experimental drug therapy for GBM.
  • - No other concurrent cytotoxic or noncytotoxic drug therapy for GBM.
- Concurrent analgesics, antiepileptics, or other drugs to treat symptoms or prevent complications are allowed

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00052715
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Michael Prados, MD
Principal Investigator Affiliation University of California, San Francisco
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, NIH
Overall Status Terminated
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Brain and Central Nervous System Tumors
Additional Details

OBJECTIVES:

  • - Determine the efficacy of poly ICLC and radiotherapy, in terms of total survival from date of diagnosis, in patients with newly diagnosed glioblastoma multiforme.
  • - Determine the safety and toxicity profile of this regimen in these patients.
  • - Determine the 12-month survival rate in patients treated with this regimen.
  • - Assess progression-free survival at 6 months and median progression-free survival from date of diagnosis of patients treated with this regimen.
  • - Assess response in patients treated with this regimen.
  • - Assess changes in neurological status in patients treated with this regimen.
OUTLINE: This is a multicenter study. Within 1-4 weeks after surgery, patients receive poly ICLC intramuscularly 3 times weekly (on days 1, 3, and 5). Treatment continues in the absence of disease progression or unacceptable toxicity. One week after the initiation of poly ICLC, patients undergo external beam radiotherapy once daily 5 days a week for 6 weeks. Patients are followed monthly for 1 year and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study within 2 years.

Arms & Interventions

Arms

Experimental: poly-ICLC Newly diagnosed GBM

Poly-ICLC 20ug/kg 3 times a week (Monday-Wednesday-Friday) starting one week before Radiation Therapy Intramuscular injection Drug Poly-ICLC

Interventions

Drug: - poly ICLC

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

UCSF Comprehensive Cancer Center, San Francisco, California

Status

Address

UCSF Comprehensive Cancer Center

San Francisco, California, 94115

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