NCT00002657|CompletedPhase 2

SWOG-9239 Reduction of Immunosuppression Plus Interferon Alfa and Combination Chemotherapy in Treating Patients With Malignant Tumors That Develop After Organ Transplant

Phase II Trial of Sequential Modification of Immunosuppression, Interferon Alpha, and Promace-Cytabom For Treatment of Post-Cardiac Transplant Lymphoproliferation.

SWOG Cancer Research Network ClinicalTrials.gov

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4 other identifiers

CDR0000064200SWOG-9239E-S9239U10CA032102

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJun 2004

StartedMay 1995

CompletionJul 2011

Brief Summary

RATIONALE: Reducing the amount of drugs used to prevent transplant rejection may help a person's body kill tumor cells. Giving biological therapy, such as interferon alfa, which may interfere with the growth of cancer cells, or combination chemotherapy, which uses different ways to stop tumor cells from dividing so they stop growing or die, may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of reducing immunosuppression, and giving interferon alfa and combination chemotherapy, in treating patients who have malignant tumors that develop after organ transplant.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_2 lymphoma

Timeline

Completed

Started May 1995

Longer than P75 for phase_2 lymphoma

Geographic Reach

1 country

86 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

16.2 years study duration

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

4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2003

Completed

8 months until next milestone

First Posted

Study publicly available on registry

June 22, 2004

Completed

7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed

Last Updated

January 24, 2013

Status Verified

January 1, 2013

Enrollment Period

8.5 years

First QC Date

November 1, 1999

Last Update Submit

January 22, 2013

Conditions

Lymphoma Multiple Myeloma and Plasma Cell Neoplasm

Keywords

isolated plasmacytoma of boneextramedullary plasmacytomarefractory multiple myelomaWaldenstrom macroglobulinemiastage I multiple myelomastage II multiple myelomastage III multiple myelomastage I small lymphocytic lymphomastage I grade 1 follicular lymphomastage I grade 2 follicular lymphomastage I grade 3 follicular lymphomastage I adult diffuse small cleaved cell lymphomastage I adult diffuse mixed cell lymphomastage I adult diffuse large cell lymphomastage I adult immunoblastic large cell lymphomastage I adult Burkitt lymphomastage II small lymphocytic lymphomastage II grade 1 follicular lymphomastage II grade 2 follicular lymphomastage II grade 3 follicular lymphomastage II adult diffuse small cleaved cell lymphomastage II adult diffuse mixed cell lymphomastage II adult diffuse large cell lymphomastage II adult immunoblastic large cell lymphomastage II adult Burkitt lymphomastage III small lymphocytic lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III adult diffuse small cleaved cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse large cell lymphomastage III adult immunoblastic large cell lymphomastage III adult Burkitt lymphomastage IV small lymphocytic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse large cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult Burkitt lymphomarecurrent small lymphocytic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse large cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult Burkitt lymphomacontiguous stage II grade 1 follicular lymphomacontiguous stage II grade 2 follicular lymphomacontiguous stage II grade 3 follicular lymphomacontiguous stage II adult diffuse small cleaved cell lymphomacontiguous stage II adult diffuse mixed cell lymphomacontiguous stage II adult immunoblastic large cell lymphomacontiguous stage II adult diffuse large cell lymphomacontiguous stage II adult Burkitt lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II small lymphocytic lymphomanoncontiguous stage II marginal zone lymphomarecurrent marginal zone lymphomastage I marginal zone lymphomastage III marginal zone lymphomastage IV marginal zone lymphomacontiguous stage II marginal zone lymphomacontiguous stage II small lymphocytic lymphomaextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Outcome Measures

Primary Outcomes (1)

Response
every 3 months while on protocol treatment

Secondary Outcomes (1)

overall survival
every 3 months while on treatment, then every 6 months thereafter

Study Arms (1)

Immumosuppression, IFN-a, ProMACE-CytaBOM

EXPERIMENTAL

Doses and schedules of immunosuppressive drugs (cyclosporin (or FK506), prednisone, and acyclovir) will depend on whether patients are judged to have clinically urgent disease or not. Patients who do not have a CR after initial immunosuppression will receive 3 cycles (28 days each) Interferon alpha 2b at 3.0 x 10\^6 IU/m\^2 on days 1-28. Patients who have a CR will then receive 6 additional cycles with 3 doses per week, then go onto observation. Patients who do not have a CR will then receive a maximum of 6 21-day cycles of chemotherapy, consisting of: cyclophosphamide 650 mg/m\^2 on day 1, adriamycin 25 mg/m\^2 on day 1, etoposide 120 mg/m\^2 on day 1, prednisone 60 mg/m\^2 on days 1-14, cytosine arabinoside 300 mg/m\^2 on day 8, bleomycin 5 mg/m\^2 on day 8, vincristine 1.4 mg/m\^2 on day 8, methotrexate 120 mg/m\^2 on day 8, leucovorin 25 mg/m\^2 q 6 hours on days 8-9, G-CSF 5 ug/kg/day on days 2-14, and one double strength tablet trimethoprim-sulfamethoxazole 3 times per week.

Biological: bleomycin sulfateBiological: recombinant interferon alfaDrug: cyclophosphamideDrug: cytarabineDrug: doxorubicin hydrochlorideDrug: etoposideDrug: methotrexateDrug: prednisoneDrug: vincristine sulfateProcedure: conventional surgeryRadiation: radiation therapy