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Thalidomide and Procarbazine in Treating Patients With Recurrent or Progressive Malignant Glioma

Study Purpose

RATIONALE: Thalidomide may stop the growth of malignant glioma by stopping blood flow to the tumor. Drugs used in chemotherapy, such as procarbazine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining thalidomide with procarbazine may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving thalidomide together with procarbazine works in treating patients with recurrent or progressive 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 malignant glioma.
  • - Anaplastic astrocytoma.
  • - Anaplastic oligodendroglioma.
  • - Glioblastoma multiforme.
  • - Anaplastic mixed oligoastrocytoma.
  • - Progressive or recurrent disease* after radiotherapy with or without chemotherapy NOTE: *Patients with prior low-grade glioma who progressed after therapy and are found to have high-grade glioma are eligible.
  • - Measurable disease by MRI or CT scan.
PATIENT CHARACTERISTICS: Age.
  • - 18 and over.
Performance status.
  • - Karnofsky 60-100% Life expectancy.
  • - More than 2 months.
Hematopoietic.
  • - Absolute neutrophil count ≥ 1,500/mm^3.
  • - Platelet count ≥ 100,000/mm^3.
Hepatic.
  • - Bilirubin ≤ 1.5 mg/dL.
  • - Transaminases ≤ 4 times upper limit of normal.
Renal.
  • - Creatinine ≤ 1.7 mg/dL.
Other.
  • - Not pregnant or nursing.
  • - Negative pregnancy test.
  • - Fertile patients must use 1 highly active method and 1 additional effective method of contraception for 1 month before, during, and for 4 weeks after study treatment.
  • - No concurrent serious infection.
  • - No other concurrent medical illness that would preclude study treatment.
  • - No other malignancy within the past 5 years except curatively treated carcinoma in situ of the cervix or basal cell skin cancer.
PRIOR CONCURRENT THERAPY: Biologic therapy.
  • - No prior thalidomide.
  • - No concurrent prophylactic filgrastim (G-CSF) Chemotherapy.
  • - See Disease Characteristics.
  • - At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas) - No prior procarbazine.
  • - No more than 2 prior chemotherapy regimens for malignant glioma.
Endocrine therapy.
  • - Not specified.
Radiotherapy.
  • - See Disease Characteristics.
  • - At least 3 months since prior radiotherapy.
Other.
  • - Recovered from prior therapy.
  • - More than 7 days since prior antidepressants (selective serotonin reuptake inhibitors and/or monamine oxidase inhibitors) - No concurrent antidepressants.
- No other concurrent investigational agents

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.

 NCT00079092
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.

 Wake Forest University Health Sciences
Principal Investigator

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

 Glenn J. Lesser, MDEdward G. Shaw, MDVolker W. Stieber, MD
Principal Investigator Affiliation Wake Forest University Health SciencesWake Forest University Health SciencesWake Forest University Health Sciences
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: Primary.

  • - Determine the response rate in patients with recurrent or progressive malignant glioma treated with thalidomide and procarbazine.
Secondary.
  • - Determine the progression-free survival of patients treated with this regimen.
  • - Determine the overall survival of patients treated with this regimen.
  • - Determine the quality of life of patients treated with this regimen.
  • - Determine the toxicity of this regimen in these patients.
OUTLINE: This is a multicenter study. Patients receive oral procarbazine once daily on days 1-5 and oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and then before every odd course. Patients are followed every 2 months. PROJECTED ACCRUAL: A total of 23-55 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.

CCOP - Central Illinois, Decatur, Illinois

Status

Address

CCOP - Central Illinois

Decatur, Illinois, 62526

Goldsboro, North Carolina

Status

Address

CCOP - Southeast Cancer Control Consortium

Goldsboro, North Carolina, 27534-9479

Winston-Salem, North Carolina

Status

Address

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096

CCOP - Greenville, Greenville, South Carolina

Status

Address

CCOP - Greenville

Greenville, South Carolina, 29615

CCOP - Upstate Carolina, Spartanburg, South Carolina

Status

Address

CCOP - Upstate Carolina

Spartanburg, South Carolina, 29303

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