NCT00244946

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carmustine, etoposide, cytarabine, and melphalan work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. A peripheral stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Giving white blood cells, that have been treated in the laboratory with antibodies, may make the transplant work better. Giving combination chemotherapy followed by an autologous stem cell transplant, and white blood cell infusions may be an effective treatment for non-Hodgkin's lymphoma. PURPOSE: This phase I trial is studying the side effects and best dose of white blood cell infusions when given together with combination chemotherapy, and autologous stem cell transplant in treating patients with non-Hodgkin's lymphoma that has relapsed, is refractory, or is in remission.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at P25-P50 for phase_1 lymphoma

Timeline
Completed

Started Mar 2004

Longer than P75 for phase_1 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

March 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 25, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 27, 2005

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

Enrollment Period

5.8 years

First QC Date

October 25, 2005

Last Update Submit

March 25, 2015

Conditions

Lymphoma

Keywords

nodal marginal zone B-cell lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomasplenic marginal zone lymphomastage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomarecurrent small lymphocytic lymphomastage III small lymphocytic lymphomastage IV small lymphocytic lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphoma

Outcome Measures

Primary Outcomes (1)

  • To perform a dose escalation trial of ATC armed with CD20Bi immunotherapy after PBSCT to determine the maximum tolerated dose (MTD) of ATC armed with CD20BI.

    This will be the called the maximum tolerated dose. The maximum tolerated dose (MTD) is defined as the dose level below the one at which the side effects are serious enough to prevent an increase in the dose or level of the treatment.

    When two patienst at any dose levet have their infusion stopped due to side effects.

Secondary Outcomes (3)

  • Evaluate the toxicities of ATC infusions armed with CD20Bi

    2 weeks (+/- 7 days), 1, 2, 3, 6 months (+/- 7 days) and 12, and 24 months (+/- one month) after Peripheral Blood Stem Cell Transplants (PBSCT)

  • Evaluate immune B-cell recovery after ATC infusion

    2 weeks (+/- 7 days), 1, 2, 3, 6 months (+/- 7 days) and 12, and 24 months (+/- one month) after Peripheral Blood Stem Cell Transplants (PBSCT)

  • Evaluate response rates of infusions and compare relapse rates and overall survival to historical controls

    1, 2, 4, 8, 16 and/or 24, 48 and 72 hours post infusion

Study Arms (1)

Autologous lymphocytes,carmustine,etoposide, melphalan, PBSCT

EXPERIMENTAL

* minus Day 8 ADMIT for Hydration * minus Day 7 Carmustine 300 mg/m2 x 1 dose * minus Day 6 Etoposide 100 mg/m2 q 12 hr; Cytarabine 100 mg/m2 q 12 hr * minus Day 5 Etoposide 100 mg/m2 q 12 hr; Cytarabine 100 mg/m2 q 12 hr * minus Day 4 Etoposide 100 mg/m2 q 12 hr; Cytarabine 100 mg/m2 q 12 hr * minus Day 3 Etoposide 100 mg/m2 q 12 hr; Cytarabine 100 mg/m2 q 12 hr * minus Day 2 Melphalan 140 mg/m2 x 1 dose * minus Day 1 Day of Rest * Day 0 Transplant

Biological: therapeutic autologous lymphocytesDrug: carmustineDrug: cytarabineDrug: etoposideDrug: melphalanProcedure: peripheral blood stem cell transplantation (PBSCT)

Interventions

therapeutic autologous lymphocytesBIOLOGICAL

Lymphocytes collected by standard apheresis technique either prior to or post stem cell mobilization and collection

Autologous lymphocytes,carmustine,etoposide, melphalan, PBSCT
carmustineDRUG
Autologous lymphocytes,carmustine,etoposide, melphalan, PBSCT
cytarabineDRUG
Autologous lymphocytes,carmustine,etoposide, melphalan, PBSCT
etoposideDRUG
Autologous lymphocytes,carmustine,etoposide, melphalan, PBSCT
melphalanDRUG
Autologous lymphocytes,carmustine,etoposide, melphalan, PBSCT
peripheral blood stem cell transplantation (PBSCT)PROCEDURE
Autologous lymphocytes,carmustine,etoposide, melphalan, PBSCT

Eligibility Criteria

Age15 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed CD20+ non-Hodgkin's lymphoma * Disease is refractory, relapsed, or in remission * Measurable or evaluable disease PATIENT CHARACTERISTICS: Performance status * ECOG 0-2 Life expectancy * Not specified Hematopoietic * Hemoglobin \> 8 g/dL * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 50,000/mm\^3 Hepatic * Bilirubin ≤ 2.0 mg/dL * SGOT or SGPT ≤ 2.5 times normal * No history of severe hepatic dysfunction Renal * Creatinine ≤ 2.0 mg/dL OR * Creatinine clearance ≥ 60 mL/min * No uncompensated major adrenal dysfunction * BUN \< 1.5 times normal Cardiovascular * No severe cardiac dysfunction * No major heart disease * LVEF ≥ 50% by MUGA * No uncontrolled hypertension * No congenital or acquired heart disease or cardiac arrhythmias unless cardiac consult and evaluation are done Pulmonary * DLCO ≥ 50% of normal * No symptomatic obstructive or restrictive disease Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infections * HIV negative * No significant skin breakdown from tumor or other diseases * Dental evaluation and teeth cleaning with no potential sources of infection required * No uncompensated major thyroid dysfunction PRIOR CONCURRENT THERAPY: Biologic therapy * No prior stem cell transplantation Chemotherapy * No prior total doxorubicin or daunorubicin dose ≥ 450 mg/m\^2 unless endomyocardial biopsy shows \< grade 2 drug effect AND ejection fraction ≥ 50% by gated blood pool scan Endocrine therapy * No concurrent hormonal therapy except steroids for adrenal failure, septic shock, or pulmonary toxicity or hormones for non-disease-related conditions (e.g., insulin for diabetes)

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

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

MeSH Terms

Conditions

LymphomaLymphoma, B-Cell, Marginal ZoneBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

CarmustineCytarabineEtoposideMelphalanPeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, B-CellEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLeukemia, LymphoidLeukemiaHematologic DiseasesLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso CompoundsCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhenylalanineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Lawrence G. Lum, MD, DSc

    Barbara Ann Karmanos Cancer Institute

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2005

First Posted

October 27, 2005

Study Start

March 1, 2004

Primary Completion

January 1, 2010

Study Completion

March 1, 2013

Last Updated

March 26, 2015

Record last verified: 2015-03

Locations

US(1)