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PHASE II TRIAL OF 9-AMINOCAMPTOTHECIN IN ADVANCED CUTANEOUS T CELL LYMPHOMA


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

PHASE II TRIAL OF 9-AMINOCAMPTOTHECIN IN ADVANCED CUTANEOUS T CELL LYMPHOMA


OBJECTIVES: I. Assess the antitumor activity of aminocamptothecin (9-AC) administered by
72-hour infusion in patients with advanced cutaneous T-cell lymphoma. II. Assess the toxic
effects of 9-AC administered on this schedule.

OUTLINE: Single-Agent Chemotherapy. Aminocamptothecin, 9-AC, NSC-603071.

PROJECTED ACCRUAL: A total of 30 patients will be accrued; if no more than 1 response is
seen in the first 15 patients, the study will close. Probable duration of study is 18
months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically confirmed, advanced stages IIB/III/IV cutaneous
T-cell lymphoma Measurable or evaluable disease required Measurable disease includes: Skin
disease evaluated by clinical assessment grid method Lesion measurable on imaging (i.e.,
CT measurement of lymph nodes) Pure osteolytic lesion Unidimensional lesion for which a
normal measurement is available (e.g., mediastinal width on x-ray) Evaluable disease
defined as malignant disease evident on physical or radiographic exam but not measurable
by ruler or caliper, i.e.: Pelvic masses Confluent multinodular lung metastases Skin
metastases CNS metastases eligible if stable for at least 4 weeks following completion of
surgery or radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At
least 3 months Hematopoietic: ANC at least 1,500 Platelets at least 100,000 Hepatic:
Bilirubin no greater than 1.5 mg/dL AST less than 3 times normal Renal: Creatinine no
greater than 1.5 mg/dL Other: No contraindication to indwelling central venous catheter No
active infection including HIV No other medical condition that would preclude protocol
compliance No pregnant or nursing women Adequate contraception required of fertile
patients

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior biological therapy allowed Chemotherapy:
Prior systemic chemotherapy allowed Patients with more than 1 prior regimen analyzed
separately At least 4 weeks since chemotherapy (6 weeks since nitrosoureas or mitomycin)
Endocrine therapy: Not specified Radiotherapy: Prior skin irradiation allowed At least 4
weeks since wide-field radiotherapy Surgery: Fully recovered from prior surgery Other:
Prior topical therapy allowed Prior PUVA allowed

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

John R. Murren, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Yale University

Authority:

United States: Federal Government

Study ID:

CDR0000064085

NCT ID:

NCT00002635

Start Date:

May 1995

Completion Date:

Related Keywords:

  • Lymphoma
  • stage II cutaneous T-cell non-Hodgkin lymphoma
  • stage III cutaneous T-cell non-Hodgkin lymphoma
  • stage IV cutaneous T-cell non-Hodgkin lymphoma
  • recurrent cutaneous T-cell non-Hodgkin lymphoma
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous

Name

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern UniversityChicago, Illinois  60611
New England Medical Center HospitalBoston, Massachusetts  02111
Yale Comprehensive Cancer CenterNew Haven, Connecticut  06520-8028