NCT00002635

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2 lymphoma

Timeline
Completed

Started May 1995

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1995

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2000

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2000

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

August 11, 2004

Completed
Last Updated

July 26, 2013

Status Verified

March 1, 2001

Enrollment Period

4.9 years

First QC Date

November 1, 1999

Last Update Submit

July 24, 2013

Conditions

Lymphoma

Keywords

stage II cutaneous T-cell non-Hodgkin lymphomastage III cutaneous T-cell non-Hodgkin lymphomastage IV cutaneous T-cell non-Hodgkin lymphomarecurrent cutaneous T-cell non-Hodgkin lymphoma

Interventions

filgrastimBIOLOGICAL
aminocamptothecinDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

Yale Comprehensive Cancer Center

New Haven, Connecticut, 06520-8028, United States

Location

Robert H. Lurie Comprehensive Cancer Center, Northwestern University

Chicago, Illinois, 60611, United States

Location

New England Medical Center Hospital

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, T-Cell, Cutaneous

Interventions

Filgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, T-CellLymphoma, Non-Hodgkin

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating FactorColony-Stimulating FactorsGlycoproteinsGlycoconjugatesCarbohydratesHematopoietic Cell Growth FactorsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • John R. Murren, MD

    Yale University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

August 11, 2004

Study Start

May 1, 1995

Primary Completion

April 1, 2000

Study Completion

April 1, 2000

Last Updated

July 26, 2013

Record last verified: 2001-03

Locations

US(3)