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Thiotepa Followed by Peripheral Stem Cell or Bone Marrow Transplant in Treating Patients With Malignant Glioma

Study Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Giving chemotherapy with peripheral stem cell or bone marrow transplant may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase II trial is studying how well thiotepa followed by peripheral stem cell or bone marrow transplant works in treating patients with malignant glioma.

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 N/A and Over
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - Histologically confirmed malignant glioma.
  • - Primary or recurrent glioblastoma multiforme (including gliosarcoma) following surgery and radiotherapy or prior conventional chemotherapy (e.g., carmustine or procarbazine, vincristine, and lomustine) - Recurrent or refractory anaplastic astrocytoma following any prior therapy (must be chemoresistant) - Recurrent or refractory ependymoma or primitive neuroectodermal tumor (PNET) following any prior therapy.
  • - Recurrent or refractory oligodendroglioma or oligoastrocytoma following any prior therapy (must be chemoresistant) - Evaluable disease on gadolinium-enhanced MRI.
  • - Ineligible for other high priority national or institutional study (e.g., protocol CAMP-004) PATIENT CHARACTERISTICS: Age: - Any age.
Performance status:
  • - ECOG 0-1.
Life expectancy:
  • - Not specified.
Hematopoietic:
  • - Not specified.
Hepatic:
  • - Not specified.
Renal:
  • - Creatinine less than 1.5 times normal.
Cardiovascular:
  • - LVEF at least 45% by MUGA.
Pulmonary:
  • - DLCO at least 60% of predicted OR.
  • - Approval by pulmonologist.
Other:
  • - Not pregnant or nursing.
  • - Fertile patients must use effective contraception.
  • - HIV negative.
PRIOR CONCURRENT THERAPY: Biologic therapy:
  • - Not specified.
Chemotherapy:
  • - See Disease Characteristics.
  • - No other concurrent chemotherapy.
Endocrine therapy:
  • - No concurrent anticancer hormonal therapy.
  • - No concurrent steroids as antiemetics.
Radiotherapy:
  • - See Disease Characteristics.
  • - See Surgery.
Surgery:
  • - See Disease Characteristics.
  • - For patients with glioblastoma multiforme, concurrent surgery and/or stereotactic radiosurgery to reduce tumor bulk allowed.
Other: - No concurrent acetaminophen during chemotherapy

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.

 NCT00008008
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.

 Herbert Irving Comprehensive Cancer Center
Principal Investigator

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

 Charles S. Hesdorffer, MD
Principal Investigator Affiliation Herbert Irving Comprehensive Cancer Center
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 response rate, disease-free interval, and overall survival of patients with malignant glioma treated with high-dose thiotepa followed by autologous peripheral blood stem cell transplantation.
  • - Determine the toxicity of this regimen in these patients.
  • - Determine the pharmacokinetics of this regimen in these patients.
  • - Determine whether this drug enters the cerebrospinal fluid of these patients.
OUTLINE: Following a course of induction chemotherapy with cyclophosphamide IV over 4 hours, patients receive filgrastim (G-CSF) daily until the completion of peripheral blood stem cell (PBSC) harvesting. PBSCs are collected over 3-5 days. Patients who do not mobilize sufficient cells undergo bone marrow harvest. Patients receive high-dose thiotepa IV over 5 hours on day -2. PBSCs or bone marrow are reinfused on day 0. Patients receive sargramostim (GM-CSF) subcutaneously daily beginning on day 0 and continuing until blood counts recover. Treatment repeats every 2-3 weeks for a total of 1-4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at every course, then monthly for 6 months, and then every 2 months thereafter. Patients are followed monthly for 6 months and then every 2 months thereafter. PROJECTED ACCRUAL: A total of 5-40 patients will be accrued for this study within 3 years.

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.

St. Joseph's Hospital and Medical Center, Paterson, New Jersey

Status

Address

St. Joseph's Hospital and Medical Center

Paterson, New Jersey, 07503

New York, New York

Status

Address

Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

New York, New York, 10032

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