NCT Number: NCT00002635
Aminocamptothecin in Treating Patients With T-cell Lymphoma
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of aminocamptothecin in treating patients with advanced cutaneous T-cell lymphoma.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Yale Comprehensive Cancer Center, New Haven, Connecticut, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
aminocamptothecin
DrugSponsors and collaborators
Lead sponsor
Yale University
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
PHASE II TRIAL OF 9-AMINOCAMPTOTHECIN IN ADVANCED CUTANEOUS T CELL LYMPHOMA
Important dates
- Study start
- 1995
- Primary completion
- 2000
- Study completion
- 2000
- First posted
- Aug 11, 2004
- Registry last updated
- Jul 26, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Carmustine, Etoposide, Cyclophosphamide, and Stem Cell Transplant in Treating Patients With HIV-Associated Lymphoma
NCT00641381
Burkitt Lymphoma, DNA Virus Infections
Duarte, California, United States
View Trial DetailsRomidepsin in Treating Patients With Lymphoma, Chronic Lymphocytic Leukemia, or Solid Tumors With Liver Dysfunction
NCT01638533
Adenocarcinoma, Breast Diseases
Duarte, California, United States
View Trial DetailsAlloHCT From Matched Unrelated Donors in Pts w/ Advanced Hematologic Malignancies & Disorders
NCT00547196
Blast Crisis, Bone Marrow Diseases
Phoenix, Arizona, United States
View Trial DetailsCardiac Magnetic Resonance Imaging in Patients With Non-Hodgkin Lymphoma or Hodgkin Lymphoma Receiving Doxorubicin
NCT00577798
Blood Protein Disorders, Burkitt Lymphoma
Omaha, Nebraska, United States
View Trial Details