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A Phase I Study to Evaluate MAG-CPT (PNU 166148) Given as One Single Intravenous Administration Every 4 Weeks in Patients With Advanced Solid Tumors

Phase 1
18 Years
Open (Enrolling)
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Study to Evaluate MAG-CPT (PNU 166148) Given as One Single Intravenous Administration Every 4 Weeks in Patients With Advanced Solid Tumors

OBJECTIVES: I. Determine the safety profile, maximum tolerated dose, and dose limiting
toxicities of PNU 166148 in patients with metastatic, refractory solid tumors. II. Define a
recommended dose of PNU 166148 for a Phase II study. III. Determine the pharmacokinetic
profile and molecular weight distribution of PNU 166148 and the pharmacokinetic profile of
free camptothecin in these patients. IV. Assess any evidence of antitumor activity in these
patients treated with this regimen.

OUTLINE: This is a dose escalation, open label, multicenter study. Patients receive PNU
166148 IV over 30 minutes. Treatment repeats every 4 weeks for 3-6 courses in the absence of
disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating
doses of PNU 166148 until the maximum tolerated dose (MTD) is determined. The MTD is defined
as the dose at which at least 2 of 3-6 patients experience dose limiting toxicity. Patients
are followed for 30 days, and then monthly thereafter only for resolution of adverse events
that occurred while on study and were attributable to study drug, unless another antitumor
treatment is begun.

PROJECTED ACCRUAL: A maximum of 30 patients will be accrued for this study.

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically proven metastatic, refractory solid tumors for
which no curative therapy exists No more than 2 prior chemotherapy regimens for metastatic
disease No prior high dose chemotherapy regimen requiring bone marrow transplantation or
peripheral blood stem cell transplantation No hematologic malignancies No brain or
leptomeningeal disease

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life
expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 2,000/mm3
Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal (no greater than 1.5 times
upper limit of normal (ULN) if liver metastases present) SGOT and SGPT normal (no greater
than 5 times ULN if liver metastases present) Hepatitis B negative Renal: Creatinine less
than 1.5 mg/dL EDTA clearance greater than 60 mL/min Other: Not pregnant or nursing
Fertile patients must use effective contraception during and for 6 months after study No
severe concurrent nonmalignant disease that would preclude protocol therapy HIV negative
No AIDS related illness No mental incapacity

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks
since prior immunotherapy and recovered No concurrent biological response modifier therapy
or immunotherapy No concurrent prophylactic growth factors Chemotherapy: See Disease
Characteristics No prior camptothecins (e.g., irinotecan or topotecan) At least 4 weeks
since other prior chemotherapy (6 weeks for nitrosoureas and mitomycin) and recovered No
other concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior hormonal
therapy and recovered No concurrent corticosteroids used as anticancer therapy No other
concurrent hormonal therapy Radiotherapy: No prior radiotherapy to greater than 25% of
bone marrow At least 4 weeks since other prior radiotherapy and recovered No concurrent
radiotherapy Surgery: Not specified Other: No concurrent investigational drug or
participation in other clinical study

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Chris Twelves, MD, BMedSci, FRCP

Investigator Role:

Study Chair

Investigator Affiliation:

University of Glasgow


United States: Federal Government

Study ID:




Start Date:

June 1999

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • Neoplasms