NCT00006373

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell or bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by autologous bone marrow transplantation or peripheral stem cell transplantation in treating patients who have non-Hodgkin's lymphoma or Hodgkin's lymphoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
27

participants targeted

Target at P25-P50 for phase_2 lymphoma

Timeline
Completed

Started Feb 2000

Longer than P75 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, 2000

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
2.3 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
5.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 4, 2013

Status Verified

June 1, 2013

Enrollment Period

6.7 years

First QC Date

October 4, 2000

Last Update Submit

June 3, 2013

Conditions

Lymphoma

Keywords

stage III adult Hodgkin lymphomastage IV adult Hodgkin lymphomarecurrent adult Hodgkin 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 lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent 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)

  • Progression-free survival

    Progression-free survival as defined as the time from date of enrollment to the time of recurrence

    3 years

Study Arms (1)

TIME

EXPERIMENTAL

Topotecan, Ifosfamide, Mesna and Etoposide

Drug: etoposideDrug: ifosfamideDrug: topotecan hydrochlorideProcedure: autologous bone marrow transplantationDrug: Mesna

Interventions

etoposideDRUG

Etoposide IV 500 mg/m2/day over 24 hours Days -5, -4, -3

Also known as: vepesid(R), VP-16
TIME
ifosfamideDRUG

Ifosfamide 3,333 mg/m2/day IV over 2 hours (total dose 10,000 mg/m2)Days -8, -7, -6

Also known as: Ifex(R)
TIME
topotecan hydrochlorideDRUG

Topotecan 21.3 mg/m2/day (total dose 64 mg/m2 ) IV over 30 minutes Days -8, -7, -6

Also known as: topotecan
TIME
autologous bone marrow transplantationPROCEDURE
TIME
MesnaDRUG

Mesna 1,111 mg/m2/dose IV over 30 minutes; 30 minutes before and 4 and 8 hours after ifosfamide (total dose 10,000 mg/m2) Days -8, -7, -6

Also known as: Mesnex(R)
TIME

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: * Histologically confirmed non-Hodgkin's lymphoma * No lymphoblastic lymphoma * Under 55 years of age: * Intermediate and high grade or aggressive disease that has relapsed and/or failed at least 2 salvage chemotherapy regimens OR * Failed to achieve complete response after first line induction chemotherapy and failed at least 1 salvage chemotherapy regimen * Low grade or indolent disease that has relapsed or failed to achieve complete response after first line induction chemotherapy and failed more than 2 salvage chemotherapy regimens * 55 years of age and over: * Intermediate and high grade or aggressive disease that has relapsed and/or failed to achieve complete response after first line induction chemotherapy * Low grade or indolent disease that has relapsed or failed to achieve complete response after first line induction chemotherapy OR * Histologically confirmed Hodgkin's lymphoma * Under 55 years of age: * Received at least 2 prior salvage chemotherapy regimens * 55 years of age and over: * Stage III or IV disease that has relapsed or failed to achieve remission after combination induction chemotherapy * Prior primary radiotherapy allowed if relapse is high risk (e.g., recurrence in radiation field, B symptoms, or liver or bone marrow involvement) * No active leptomeningeal involvement or severe symptomatic CNS disease * Prior CSF tumor involvement allowed if asymptomatic and no evidence of disease on lumbar puncture or no tumor involvement on MRI of the brain * Solid tumors and brain metastases allowed * No evidence of disease by MRI and physical exam following optimal prior surgery and/or radiotherapy AND * At least 3 months since prior radiotherapy NOTE: 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 to 64 Performance status: * ECOG 0-1 Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin no greater than 2.0 mg/dL\* * SGOT or SGPT no greater than 2.5 times normal\* * No severe hepatic dysfunction NOTE: \*Unless due to primary malignancy Renal: * Creatinine no greater than 2.0 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No severe cardiac dysfunction * Ejection fraction at least 50% by MUGA scan * Essential hypertension controlled by medication allowed Pulmonary: * DLCO at least 50% of normal OR * No symptomatic obstructive or restrictive disease Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier contraception * No active infection * HIV negative * No insulin dependent diabetes mellitus * No uncompensated major thyroid or adrenal dysfunction * No significant skin breakdown from tumor or other disease * No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * See Disease Characteristics * Prior doxorubicin or daunorubicin allowed if total dose no greater than 450 mg/m2 * No prior topotecan Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics Surgery: * See Disease Characteristics Other: * No concurrent nitroglycerin preparations for angina pectoris * No concurrent antiarrhythmic drugs for major ventricular arrhythmias

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

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

MeSH Terms

Conditions

LymphomaHodgkin DiseaseLymphoma, FollicularLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Large-Cell, ImmunoblasticBurkitt LymphomaLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-Cell

Interventions

EtoposideIfosfamideTopotecanMesna

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, B-CellLeukemia, LymphoidLeukemiaHematologic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesCyclophosphamidePhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedPhosphoramidesOrganophosphorus CompoundsOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsCamptothecinAlkaloidsAlkanesulfonatesAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicSulfhydryl CompoundsSulfur CompoundsSulfonic AcidsSulfur Acids

Study Officials

  • Steven C. Goldstein, MD

    H. Lee Moffitt Cancer Center and Research Institute

    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

October 4, 2000

First Posted

January 27, 2003

Study Start

February 1, 2000

Primary Completion

October 1, 2006

Study Completion

December 1, 2011

Last Updated

June 4, 2013

Record last verified: 2013-06

Locations

US(1)