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Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Glioblastoma Multiforme

Phase 2
18 Years
Not Enrolling
Brain and Central Nervous System Tumors

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Trial Information

Open Label Phase II Study on RFS 2000 (9-Nitro-Camptothecin, 9-NC) Administered as a "5 Days On-2 Days Off" Oral Treatment in Glioblastoma Multiforme

OBJECTIVES: I. Assess the therapeutic activity and toxicities of nitrocamptothecin in
patients with glioblastoma multiforme. II. Determine the overall response, duration of
response, and progression free survival of these patients after this treatment.

OUTLINE: This is a multicenter study. Patients receive nitrocamptothecin orally daily on
days 1-5. Treatment continues every 7 days in the absence of disease progression or
unacceptable toxicity. Patients are followed every 6 weeks until disease progression in the
absence of further treatment.

PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed glioblastoma multiforme
Recurrent disease confirmed by CT or MRI Bidimensionally measurable disease At least one
lesion with the largest diameter at least 2 cm

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count
at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN)
Alkaline phosphatase and transaminases no greater than 2.5 times ULN (no greater than 5
times ULN in case of liver metastases) Renal: Creatinine no greater than 1.7 mg/dL
Cardiovascular: No history of ischemic heart disease in past 6 months Other: Not pregnant
or nursing Fertile patients must use effective contraception No other prior or concurrent
malignancies except cone biopsied carcinoma of the cervix or adequately treated basal or
squamous cell skin carcinoma No other unstable systemic disease No active uncontrolled
infection No psychological, familial, sociological, or geographical condition that would
preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 6 weeks
since prior adjuvant chemotherapy No other prior or concurrent chemotherapy allowed
Endocrine therapy: Concurrent corticosteroids allowed Stable or decreasing dose for at
least 2 weeks Radiotherapy: No high dose radiotherapy, stereotactic radiosurgery, or
internal radiotherapy unless recurrence is histologically confirmed At least 3 months
since prior radiotherapy to the brain Surgery: No prior surgery for recurrent brain tumor
except biopsy At least 3 months since prior surgery for primary brain tumor Other: No
other concurrent anticancer therapy No other concurrent investigational therapy

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Eric Raymond, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris


United States: Federal Government

Study ID:




Start Date:

March 2000

Completion Date:

Related Keywords:

  • Brain and Central Nervous System Tumors
  • adult glioblastoma
  • adult giant cell glioblastoma
  • adult gliosarcoma
  • Glioblastoma
  • Nervous System Neoplasms
  • Central Nervous System Neoplasms