Topotecan and Thalidomide in Treating Patients With Recurrent or Refractory Malignant Glioma
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| ClinicalTrials.gov Identifier: NCT00014443 |
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Recruitment Status : Unknown
Verified January 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : July 24, 2008
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Brain and Central Nervous System Tumors | Drug: thalidomide Drug: topotecan hydrochloride | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Primary Purpose: | Treatment |
| Official Title: | A Pilot Study Of Hycamtin (Topotecan) And Thalomid (Thalidomide) In Patients With Recurrent Malignant Gliomas |
| Study Start Date : | August 2000 |
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00014443
| United States, Illinois | |
| Rush Cancer Institute at Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
| Study Chair: | Pam G. Khosla, MD | Rush University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00014443 |
| Other Study ID Numbers: |
CDR0000068544 RUSH-G101 NCI-V01-1651 |
| First Posted: | January 27, 2003 Key Record Dates |
| Last Update Posted: | July 24, 2008 |
| Last Verified: | January 2006 |
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recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult giant cell glioblastoma adult gliosarcoma |
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Glioma Nervous System Neoplasms Central Nervous System Neoplasms Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms by Site Nervous System Diseases Thalidomide Topotecan Topoisomerase I Inhibitors |
Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors |