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Phase I of Intrathecal Melphalan in Patients With Recurrent Neoplastic Meningitis


Phase 1
3 Years
N/A
Not Enrolling
Both
Brain and Central Nervous System Tumors, Extragonadal Germ Cell Tumor, Leukemia, Lymphoma, Ovarian Cancer

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Trial Information

Phase I of Intrathecal Melphalan in Patients With Recurrent Neoplastic Meningitis


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.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed malignancy that is metastatic to the CSF
or leptomeningeal/subarachnoid space, including the following: Leukemia Lymphoma Germ cell
tumors Persistent or recurrent disease required Cytologic evidence of malignancy in CSF or
evidence of leptomeningeal tumor by CT or MRI No obstructive hydrocephalus or complete
block of spinal CSF pathways on pre- study MRI or CT No rapidly progressing or
deteriorating neurological deficit

PATIENT CHARACTERISTICS: Age: 3 and over Performance status: Karnofsky 60-100% (age 10 and
over) OR Lansky 60-100% (age under 10) Life expectancy: At least 8 weeks Hematopoietic:
Absolute neutrophil count greater than 1,000/mm3* Platelet count greater than 100,000/mm3*
* Lower values allowed with approval of the investigator Hepatic: Bilirubin less than 3.0
mg/dL Renal: Creatinine less than 2 mg/dL Blood urea nitrogen less than 30 mg/dL
Electrolytes (including calcium, magnesium, phosphate) normal Other: No active infection
Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior systemic
chemotherapy within 3 weeks of entry allowed at investigator's discretion At least 3 weeks
since prior intrathecal chemotherapy No other concurrent intrathecal chemotherapy
Endocrine therapy: Not specified Radiotherapy: At least 3 weeks since prior radiotherapy
to the CNS No concurrent radiotherapy to the CNS Surgery: Not specified

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Henry S. Friedman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

2117

NCT ID:

NCT00002750

Start Date:

December 1992

Completion Date:

May 2001

Related Keywords:

  • Brain and Central Nervous System Tumors
  • Extragonadal Germ Cell Tumor
  • Leukemia
  • Lymphoma
  • Ovarian Cancer
  • recurrent childhood acute lymphoblastic leukemia
  • recurrent adult Hodgkin lymphoma
  • Waldenström macroglobulinemia
  • recurrent childhood lymphoblastic lymphoma
  • childhood central nervous system germ cell tumor
  • recurrent childhood acute myeloid leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • recurrent/refractory childhood Hodgkin lymphoma
  • recurrent ovarian germ cell tumor
  • recurrent adult non-Hodgkin lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • extragonadal germ cell tumor
  • leptomeningeal metastases
  • recurrent childhood small noncleaved cell lymphoma
  • recurrent childhood large cell lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Leukemia
  • Lymphoma
  • Meningitis
  • Nervous System Neoplasms
  • Ovarian Neoplasms
  • Central Nervous System Neoplasms
  • Neoplasms, Germ Cell and Embryonal
  • Meningeal Carcinomatosis

Name

Location
Duke Comprehensive Cancer Center Durham, North Carolina  27710