Topotecan and Thalidomide in Treating Patients With Recurrent or Refractory Malignant Glioma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by National Cancer Institute (NCI).
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Rush University Medical Center
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00014443
First received: April 10, 2001
Last updated: July 23, 2008
Last verified: January 2006
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors |
Drug: thalidomide Drug: topotecan hydrochloride |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Pilot Study Of Hycamtin (Topotecan) And Thalomid (Thalidomide) In Patients With Recurrent Malignant Gliomas |
Resource links provided by NLM:
Genetic and Rare Diseases Information Center resources:
Anaplastic Astrocytoma
Brain Tumor, Adult
Glioblastoma
Glioma
Gliosarcoma
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
| Estimated Enrollment: | 20 |
| Study Start Date: | August 2000 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00014443
Please refer to this study by its ClinicalTrials.gov identifier: NCT00014443
Locations
| United States, Illinois | |
| Rush Cancer Institute at Rush University Medical Center | |
| Chicago, Illinois, United States, 60612 | |
Sponsors and Collaborators
Rush University Medical Center
Investigators
| Study Chair: | Pam G. Khosla, MD | Rush University Medical Center |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00014443 History of Changes |
| Other Study ID Numbers: | CDR0000068544, RUSH-G101, NCI-V01-1651 |
| Study First Received: | April 10, 2001 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent adult brain tumor adult glioblastoma adult anaplastic astrocytoma adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Central Nervous System Neoplasms Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Thalidomide Topotecan Angiogenesis Inhibitors Angiogenesis Modulating Agents Anti-Bacterial Agents Anti-Infective Agents Antineoplastic Agents |
Enzyme Inhibitors Growth Inhibitors Growth Substances Immunologic Factors Immunosuppressive Agents Leprostatic Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses Topoisomerase I Inhibitors Topoisomerase Inhibitors |
ClinicalTrials.gov processed this record on February 27, 2015