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Topotecan and Thalidomide in Treating Patients With Recurrent or Refractory Malignant Glioma

Study Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase I trial to study the effectiveness of combining topotecan and thalidomide in treating patients who have recurrent or refractory 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 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

DISEASE CHARACTERISTICS:

  • - Histologically confirmed recurrent or progressive supratentorial glioblastoma or anaplastic astrocytoma.
  • - Measurable disease by MRI or CT scan.
  • - No gliomatosis cerebri, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma.
  • - Concurrent registration for the System for Thalidomide Education and Prescribing Safety (S.
T.E.P.S.) program.PATIENT CHARACTERISTICS: Age:
  • - Over 18.
Performance status:
  • - ECOG 0-2.
Life expectancy:
  • - Not specified.
Hematopoietic:
  • - WBC greater than 4,000/mm^3.
  • - Platelet count greater than 100,000/mm^3.
Hepatic:
  • - Bilirubin less than 2.0 mg/dL.
Renal:
  • - Creatinine less than 1.6 mg/dL.
Other:
  • - No other concurrent malignancy except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use 2 methods of effective contraception 1 month prior to, during, and for 1 month after study participation.
PRIOR CONCURRENT THERAPY: Biologic therapy:
  • - Not specified.
Chemotherapy:
  • - No more than 2 prior chemotherapy regimens in adjuvant or metastatic setting.
  • - At least 4 weeks since prior chemotherapy.
Endocrine therapy:
  • - Not specified.
Radiotherapy:
  • - Not specified.
Surgery:
  • - Not specified.
Other: - Concurrent anticonvulsants 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.

 NCT00014443
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.

 Rush University Medical Center
Principal Investigator

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

 Pam G. Khosla, MD
Principal Investigator Affiliation Rush University Medical Center
Agency Class

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

 Other
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 tumor response rate, duration of response, time to disease progression, and overall survival of patients with recurrent or refractory malignant glioma treated with topotecan and thalidomide.
  • - Determine safety and tolerance of this regimen in these patients.
OUTLINE: Patients receive topotecan IV continuously on days 1-21 and oral thalidomide daily on days 1-28. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months. PROJECTED ACCRUAL: Approximately 20 patients will be accrued for this study within 2 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.

Chicago, Illinois

Status

Address

Rush Cancer Institute at Rush University Medical Center

Chicago, Illinois, 60612

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