Clinical Trial: Melphalan in Patients With Neoplastic Meningitis

This study is no longer recruiting patients.

Sponsored by: Duke Comprehensive 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. PURPOSE: Phase I trial to study the effectiveness of melphalan in patients with persistent or recurrent neoplastic meningitis.

Condition Treatment or Intervention Phase
Lymphoma
Leukemia
Brain Tumor
 Drug: melphalan
Phase I

MedlinePlus related topics:  Brain Cancer;   Leukemia, Adult Acute;   Leukemia, Adult Chronic;   Leukemia, Childhood;   Lymphoma

Study Type: Interventional
Study Design: Treatment

Official Title: Phase I Study of Intrathecal Melphalan for Neoplastic Meningitis

Further Study Details: 

Study start: December 1992

OBJECTIVES: I. Estimate the maximum tolerated dose of intrathecal melphalan (L-PAM) that can be given in patients with neoplastic meningitis. II. Determine the cerebrospinal fluid and serum pharmacokinetics of L-PAM administered via an Ommaya reservoir.

PROTOCOL OUTLINE: Single-Agent Intrathecal Chemotherapy. Melphalan, L-PAM, NSC-8806.

PROJECTED ACCRUAL: At least 3 children and 3 adults will be treated at each dose studied in Escalation 2.

Eligibility

Ages Eligible for Study:  3 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

--Patient Characteristics--

  • Age: 3 and over
  • Performance status: Karnofsky 60%-100% (Lansky 60%-100% in children under 10 years)
  • Life expectancy: At least 8 weeks
  • Hematopoietic: (lower values allowed with approval of the investigator) ANC greater than 1,000; Platelets greater than 100,000
  • Hepatic: Bilirubin less than 3.0 mg/dL
  • Renal: Creatinine less than 2 mg/dL; BUN less than 30 mg/dL; Electrolytes (including calcium, magnesium, phosphate) normal
  • Other: No active infection; Negative pregnancy test required of fertile women; Effective contraception required of fertile women

Location Information


North Carolina
      Duke Comprehensive Cancer Center, Durham,  North Carolina,  27710,  United States

Study chairs or principal investigators

Henry S. Friedman,  Study Chair,  Duke Comprehensive Cancer Center   

More Information

Study ID Numbers:  CDR0000064684; DUMC-1961-99-11R7; NCI-V96-0869; DUMC-1631-96-11R4; DUMC-1728-97-11R5; DUMC-1818-98-11R6
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002750
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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