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Biological Therapy Following Surgery and Radiation Therapy in Treating Patients With Primary or Recurrent Astrocytoma or Oligodendroglioma

Study Purpose

RATIONALE: Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing. Combining different types of biological therapies may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of biological therapy following surgery and radiation therapy in treating patients who have primary or recurrent astrocytoma or oligodendroglioma.

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 proven grade II, III, or IV astrocytoma or oligodendroglioma.
  • - Evidence of primary or recurrent tumor by MRI.
  • - Resectable disease.
  • - At least 20,000,000 viable cells obtained from surgical specimen for use in the immunization part of this study.
PATIENT CHARACTERISTICS: Age:
  • - 18 and over.
Performance status:
  • - SWOG 0 or 1.
Life expectancy:
  • - At least 6 months.
Hematopoietic:
  • - Granulocyte count at least 1,500/mm^3.
  • - Platelet count at least lower limit of normal.
  • - No active or recent uncontrolled bleeding.
Hepatic:
  • - Bilirubin normal.
  • - SGOT no greater than 2 times upper limit of normal (ULN) (5 times ULN if liver metastases are present) Renal: - Creatinine normal.
Other:
  • - Able to be weaned off steroids.
  • - Negative stool guaiac.
  • - No impaired immunity.
  • - No uncontrolled diabetes.
  • - No active uncontrolled infections.
  • - No other serious disease.
  • - No other malignancies within the past 5 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the cervix.
  • - No psychological, familial, sociological, or geographical conditions that would preclude compliance.
PRIOR CONCURRENT THERAPY: Biologic therapy:
  • - Not specified.
Chemotherapy:
  • - No concurrent chemotherapy except for progressive disease.
Endocrine therapy:
  • - See Disease Characteristics.
Radiotherapy:
  • - Radium implants allowed.
Surgery:
  • - Not specified.
Other. - At least 1 week since prior therapy and recovered

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.

 NCT00004024
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.

 Barbara Ann Karmanos Cancer Institute
Principal Investigator

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

 Andrew E. Sloan, MD
Principal Investigator Affiliation Barbara Ann Karmanos Cancer Institute
Agency Class

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

 Other, NIH
Overall Status Completed
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 immunotherapy with irradiated autologous tumor cell vaccine and adoptive immunotherapy, in terms of time to progression and median and one-year survival, in patients with primary or recurrent malignant astrocytoma or oligodendroglioma.
  • - Determine the immunogenicity of malignant gliomas in patients treated with this regimen.
OUTLINE: Patients are stratified according to extent of disease, extent of antigen-specific response to vaccination, performance status (0 vs.#46;1), prior therapy (yes vs.#46;no), and gender. Patients undergo tumor resection on week 1. Patients without recurrent disease receive local radiotherapy on weeks 2-8. Beginning week 10-12, patients are vaccinated with irradiated autologous tumor cells and sargramostim (GM-CSF) and then receive GM-CSF alone intradermally at vaccination sites daily for 4 days. Patients are revaccinated 4 weeks later and may receive up to 3 additional vaccinations every 2 weeks until a response is detected. Patients undergo peripheral blood mononuclear cell collection on week 14 followed by monoclonal antibody OKT3-activated T lymphocytes IV over 1-6 hours with alternating interleukin-2 IV once every other day for 5 doses over 10 days beginning on week 16. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients may receive one additional course of immunotherapy as above. Patients are followed at 1 week, monthly for 3 months, every 3 months for 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.

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.

Barbara Ann Karmanos Cancer Institute, Detroit, Michigan

Status

Address

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379

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