NCT00002745

Brief Summary

Phase II trial to study the effectiveness of aminocamptothecin in treating patients who have refractory or recurrent Hodgkin's disease or non-Hodgkin's lymphoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for phase_2 lymphoma

Timeline
Completed

Started Apr 1996

Longer than P75 for phase_2 lymphoma

Geographic Reach
1 country

5 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

April 1, 1996

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2003

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

April 22, 2004

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
Last Updated

February 11, 2013

Status Verified

January 1, 2013

Enrollment Period

7 years

First QC Date

November 1, 1999

Last Update Submit

February 8, 2013

Conditions

Lymphoma

Keywords

Waldenstrom macroglobulinemiarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent small lymphocytic lymphoma

Outcome Measures

Primary Outcomes (1)

  • Response

    2 years post treatment

Secondary Outcomes (2)

  • Toxicity

    day 1 of each cycle

  • 9-AC/DMA concentrations

    Pre-treatment cycle 1 and just prior to completion of cycle 1

Study Arms (1)

aminocamptothecin

EXPERIMENTAL

aminocamptothecin

Drug: aminocamptothecin

Interventions

aminocamptothecinDRUG

850 micrograms/square meter/day (total dose 2550 micrograms/square meter) via central venous catheter using infusion pump over 72 hours + one cycle Cycle repeated every 14 days for minimum of 6 cycles if partial or complete response

aminocamptothecin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically documented Hodgkin's disease (closed to accrual 4/15/2000) OR * Histologically documented non-Hodgkin's lymphoma (NHL) of one of the following International Working Formulation (IWF) histologies: * Small lymphocytic (absolute lymphocyte count less than 5,000) * IWF A Follicular, predominantly small cleaved cell * IWF B Follicular mixed * IWF C Follicular large cell * IWF D\* Diffuse small cleaved cell * IWF E\* Diffuse mixed * IWF F\* Diffuse large cell * IWF G\* Large cell, immunoblastic * IWF H\* \* Accrual of patients with these diagnoses closed 4/15/2000 * Pathology review required within 60 days of registration * Refractory to or relapsed after prior chemotherapy as follows: * Low-grade NHL (IWF A-C): 1 or 2 prior therapies * Intermediate-grade NHL (IWF D-H): 1 prior therapy (stratum closed 4/15/2000) * Hodgkin's disease: 1 or 2 prior therapies (stratum closed 4/15/2000) * Treatment with the same drugs on 2 different schedules considered 1 therapy * Measurable disease by physical exam or imaging studies * Mass larger than 1 x 1 cm * Documented progression required of previously irradiated lesions * The following are not considered measurable: * Ascites or pleural effusion * Bone marrow involvement * Positive barium studies * Bony disease (lytic lesions noted) * No mantle cell or transformed lymphoma * No parenchymal or leptomeningeal CNS disease * A new classification scheme for adult non-Hodgkin's lymphoma has been adopted by PDQ. The terminology of "indolent" or "aggressive" lymphoma will replace the former terminology of "low", "intermediate", or "high" grade lymphoma. However, this protocol uses the former terminology. PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: CALGB 0-2 * Unless hypersplenism or biopsy-proven bone marrow involvement: * Absolute granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 * Bilirubin normal * AST no greater than 4 times normal * Creatinine normal * No suspected HIV infection * No second malignancy within past 5 years except: * Curatively treated carcinoma of the cervix * Curatively treated basal cell skin cancer * No uncontrolled infection or other serious medical condition * No psychiatric condition that precludes informed consent * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * No prior allogeneic or autologous bone marrow transplant * More than 3 weeks since chemotherapy (6 weeks since nitrosoureas, melphalan, or mitomycin) * No prior camptothecin * More than 3 weeks since radiotherapy

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

Sponsors & Collaborators

Study Sites (5)

Walter Reed Army Medical Center

Washington D.C., District of Columbia, 20307-5000, United States

Location

University of Minnesota Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Washington University Barnard Cancer Center

St Louis, Missouri, 63110, United States

Location

Cooper Cancer Institute

Camden, New Jersey, 08103, United States

Location

St. Joseph's Hospital and Medical Center

Paterson, New Jersey, 07503, United States

Location

Related Publications (1)

  • Bartlett NL, Johnson JL, Wagner-Johnston N, Ratain MJ, Peterson BA; Cancer and Leukemia Group B. Phase II study of 9-aminocamptothecin in previously treated lymphomas: results of Cancer and Leukemia Group B 9551. Cancer Chemother Pharmacol. 2009 Apr;63(5):793-8. doi: 10.1007/s00280-008-0803-x. Epub 2008 Jul 23.

    PMID: 18648813RESULT

MeSH Terms

Conditions

LymphomaWaldenstrom MacroglobulinemiaLymphoma, FollicularLeukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemorrhagic DisordersLymphoma, Non-HodgkinLeukemia, B-CellLeukemia, LymphoidLeukemiaChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Nancy L. Bartlett, MD

    Washington University Siteman Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 22, 2004

Study Start

April 1, 1996

Primary Completion

April 1, 2003

Study Completion

January 1, 2008

Last Updated

February 11, 2013

Record last verified: 2013-01

Locations

US(5)