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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Brain and Central Nervous System Tumors

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Pam G. Khosla, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Rush University Medical Center

Authority:

United States: Federal Government

Study ID:

CDR0000068544

NCT ID:

NCT00014443

Start Date:

August 2000

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • recurrent adult brain tumor
  • adult glioblastoma
  • adult anaplastic astrocytoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms
  • Glioma

Name

Location

Rush Cancer Institute at Rush University Medical CenterChicago, Illinois  60612