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Combination Chemotherapy for Patients With Brain Cancer - Article


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Brain Tumor

Brain Cancer; Brain Cancer (Brain Tumor); Brain Tumors; Cancer, Brain 




Clinical Trial: Combination Chemotherapy for Patients With Brain Cancer

This study is no longer recruiting patients.

Sponsored by: Norris Cotton Cancer Center
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy using paclitaxel and topotecan, plus G-CSF, in treating patients with glioblastoma multiforme or anaplastic astrocytoma that is refractory or recurrent.

Condition Treatment or Intervention Phase
adult glioblastoma multiforme
adult anaplastic astrocytoma
recurrent adult brain tumor
 Drug: filgrastim
 Drug: paclitaxel
 Drug: topotecan
Phase II

MedlinePlus related topics:  Brain Cancer;   Cancer;   Cancer Alternative Therapy

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Study of Paclitaxel/Topotecan/G-CSF for Recurrent Glioblastoma Multiforme or Anaplastic Astrocytoma

Further Study Details: 

Study start: August 1996

OBJECTIVES: I. Determine the response rate in patients with refractory or recurrent glioblastoma multiforme or anaplastic astrocytoma treated with paclitaxel (TAX) and topotecan (TOPO) with granulocyte colony-stimulating factor (G-CSF) support. II. Determine survival in these patients. III. Describe the toxicity of TAX/TOPO/G-CSF. IV. Evaluate tumor p53 expression in relation to response to TAX/TOPO/G-CSF.

PROTOCOL OUTLINE: All patients receive paclitaxel, topotecan, and G-CSF every 3 weeks for at least 2 courses and until 2 courses beyond maximum response. Patients are followed every 3 months for 2 years, then every 6 months for relapse and survival.

PROJECTED ACCRUAL: A total of 35 patients will be entered if there are 1-3 responses in the first 20 patients.

Eligibility

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

  • No prior taxanes or topoisomerase I inhibitors; At least 4 weeks since chemotherapy (6 weeks since nitrosoureas); At least 4 weeks since radiotherapy

--Patient Characteristics--

  • Age: 18 and over
  • Performance status: Karnofsky 60%-100%
  • Hematopoietic: WBC at least 3,000; ANC at least 1,500; Platelets at least 100,000
  • Hepatic: Bilirubin no greater than 1.0 mg/dL; AST/ALT no greater than 2.5 times normal
  • Renal: Creatinine no greater than 1.5 mg/dL
  • Other: No documented sensitivity to E. coli-derived products; No major medical or psychiatric illness that would interfere with therapy or compliance with scheduled follow-up; No pregnant or nursing women; Adequate contraception required of fertile patients

Location Information


New Hampshire
      Norris Cotton Cancer Center, Lebanon,  New Hampshire,  03756,  United States

Study chairs or principal investigators

Camilo E. Fadul,  Study Chair,  Norris Cotton Cancer Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000064961; DMS-9607; NCI-V96-0955
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002814
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005

Resources



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Page Updated: October 1, 2005
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