Trials / Completed
CompletedNCT00002750
Melphalan in Patients With Neoplastic Meningitis
Phase I of Intrathecal Melphalan in Patients With Recurrent Neoplastic Meningitis
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 6 (estimated)
- Sponsor
- Duke University · Academic / Other
- Sex
- All
- Age
- 3 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
OBJECTIVES: I. Determine the maximum tolerated dose of intrathecal melphalan (L-PAM) in patients with neoplastic meningitis. II. Determine the CSF and serum pharmacokinetics of L-PAM administered via an Ommaya reservoir to these patients. OUTLINE: This is a dose escalation study. Patients receive melphalan (L-PAM) intrathecally (IT) via lumbar puncture or Ommaya reservoir twice a week for 2 weeks. Cohorts of 3-6 patients receive escalating doses of melphalan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 4 of 6 patients experience dose-limiting toxicity. At least 3 patients receive L-PAM via Ommaya reservoir at the MTD. Patients with objective or significant clinical response may receive additional L-PAM IT once a week for 2 consecutive weeks, every other week for 2 doses, and then monthly thereafter. Patients are followed every 12 weeks for 1 year or until disease progression. PROJECTED ACCRUAL: A minimum of 3 children and 3 adults per dose level will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | melphalan |
Timeline
- Start date
- 1992-12-01
- Primary completion
- 2001-05-01
- Completion
- 2001-05-01
- First posted
- 2004-05-24
- Last updated
- 2013-02-20
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00002750. Inclusion in this directory is not an endorsement.