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

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

thalidomide

topotecan hydrochloride

About this trial

This is an interventional treatment trial for Brain and Central Nervous System Tumors focused on measuring recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rush Cancer Institute at Rush University Medical Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00014443

First Posted

April 10, 2001

Last Updated

January 5, 2023

Sponsor

Rush University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00014443

Brief Title

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

Official Title

A Pilot Study Of Hycamtin (Topotecan) And Thalomid (Thalidomide) In Patients With Recurrent Malignant Gliomas

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Terminated

Why Stopped

Poor enrollment

Study Start Date

August 2000 (Actual)

Primary Completion Date

August 2003 (Actual)

Study Completion Date

December 2003 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain and Central Nervous System Tumors

Keywords

recurrent adult brain tumor, adult glioblastoma, adult anaplastic astrocytoma, adult giant cell glioblastoma, adult gliosarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

5 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

thalidomide

Intervention Type

Drug

Intervention Name(s)

topotecan hydrochloride

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

No

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pam G. Khosla, MD

Organizational Affiliation

Rush University Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Rush Cancer Institute at Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Brain and Central Nervous System Tumors

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial