Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Aminocamptothecin in Treating Patients With T-cell Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Completed	18 and over	NCI	YALE-HIC-7862 NCI-T94-0189D, NCT00002635, T94-0189

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.

Entry 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

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

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

Expected Enrollment

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.

Outline

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

Trial Contact Information

Trial Lead Organizations

Yale Cancer Center

John Murren, MD, Protocol chair(Contact information may not be current)		Ph: 203-785-4095; 866-925-3226

Registry Information
Official Title		PHASE II TRIAL OF 9-AMINOCAMPTOTHECIN IN ADVANCED CUTANEOUS T CELL LYMPHOMA
Trial Start Date		1995-05-01
Registered in ClinicalTrials.gov		NCT00002635
Date Submitted to PDQ		1995-05-01
Information Last Verified		2001-03-01