NCT00002829

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage cancer cells, and may be an effective treatment for lymphoma. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells. PURPOSE: Phase II trial to study the effectiveness of bone marrow transplantation in treating patients with recurrent or residual low-grade lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P50-P75 for phase_2 lymphoma

Timeline
Completed

Started Feb 1994

Typical duration for phase_2 lymphoma

Geographic Reach
1 country

1 active site

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

February 1, 1994

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2002

Completed
2.2 years until next milestone

First Posted

Study publicly available on registry

May 26, 2004

Completed
Last Updated

July 30, 2012

Status Verified

July 1, 2012

Enrollment Period

8.2 years

First QC Date

November 1, 1999

Last Update Submit

July 26, 2012

Conditions

Lymphoma

Keywords

Waldenstrom macroglobulinemiarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomaextranodal marginal zone B-cell lymphomamucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphoma

Outcome Measures

Primary Outcomes (1)

  • Number of Patients with Response

    2 Years

Study Arms (1)

Bone Marrow Transplantation

EXPERIMENTAL
Biological: Recombinant Interferon AlfaDrug: CyclophosphamideDrug: EtoposideDrug: MesnaProcedure: Bone Marrow TransplantationRadiation: Radiation Therapy

Interventions

Recombinant Interferon AlfaBIOLOGICAL

Daily

Bone Marrow Transplantation
CyclophosphamideDRUG

Infused intravenously over 2 hours daily on Day -7 and -6.

Also known as: Cytoxan, Neosar
Bone Marrow Transplantation
EtoposideDRUG

Administered intravenously on Day -8

Also known as: VePesid
Bone Marrow Transplantation
MesnaDRUG

Beginning 1 hour after initiation of the cyclophosphamide treatment.

Also known as: Mesnex
Bone Marrow Transplantation
Bone Marrow TransplantationPROCEDURE

Infusion on Day 0.

Also known as: BMT
Bone Marrow Transplantation
Radiation TherapyRADIATION

Total body irradiation is received on days -4, -3, -2 , and -1.

Also known as: RT, Radiotherapy, TBI
Bone Marrow Transplantation

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
DISEASE CHARACTERISTICS: Histologically proven low grade lymphoma in the following settings: Consolidation of newly diagnosed stage IV high-risk patients after 6-9 months of intensive conventional dose chemotherapy involving doxorubicin High risk is defined as \>=5 cm adenopathy and \>=2 extranodal sites at diagnosis, or males with \>=5 cm adenopathy and \> 20% marrow infiltrate at diagnosis) Failure to achieve CR within 6 months in newly diagnosed patients with intensive doxorubicin treatment Relapse patients who are sensitive to doxorubicin or ESHAP chemotherapies Patients with resistant chemotherapy failure (allogeneic BMT only) Patients with HLA-identical sibling donors are eligible for allogeneic bone marrow transplantation; other patients are eligible for autologous marrow transplantation Bone marrow must be in complete or near complete remission (\< 15 % malignant cells) in autologous transplant patients PATIENT CHARACTERISTICS: Age: 15 to 60 years Performance Status: Zubrod 0-2 Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: Cardiac ejection fraction at least 50% Pulmonary: DLCO at least 50% Other: No concomitant severe medical illnesses No psychosis PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed Endocrine therapy: Not specified Radiotherapy: No prior extensive radiotherapy Surgery: Not specified

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

Sponsors & Collaborators

Study Sites (1)

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

LymphomaWaldenstrom MacroglobulinemiaLymphoma, FollicularLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

Interferon-alphaCyclophosphamideEtoposideMesnaBone Marrow TransplantationRadiotherapy

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-HodgkinLymphoma, B-CellLeukemia, B-CellLeukemia, LymphoidLeukemiaChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Interferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicSulfhydryl CompoundsSulfur CompoundsSulfonic AcidsSulfur AcidsTissue TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Richard E. Champlin, MD

    M.D. Anderson Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

May 26, 2004

Study Start

February 1, 1994

Primary Completion

April 1, 2002

Study Completion

April 1, 2002

Last Updated

July 30, 2012

Record last verified: 2012-07

Locations

US(1)