Autologous Stem Cell Transplant in Treating Patients With Progressive or Recurrent Hodgkin's Lymphoma

NCT00265889 | Completed Phase 2 Results

• 3 other identifiers: CCF5386P30CA043703CCF-5386
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Giving two autologous stem cell transplants (one after the other) may be an effective treatment for Hodgkin's lymphoma. PURPOSE: This phase II trial is studying how well giving two autologous stem cell transplants works in treating patients with progressive or recurrent Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma

Outcome Measures

Primary Outcomes (3)

• Progression-free Survival

  Outcome is based on the number of patients who were alive without progression or relapse within 1 year. Progression is defined as a 50% increase in the sum of products of all measurable lesions.

  one year after second transplant

• Response Rate

  Number of patients that receive a Complete Response (CR), Partial Response (PR)or Progression. CR defined as complete disappearance of all measurable and evaluable disease and no new lesions. PR is defined as \>/= 50% decrease in the sum of products of all measurable lesions. Progression is defined as a 50% increase in the sum of products of all measurable lesions.

  One year after second transplant

• Number of Patients That Experience Pulmonary Toxicity

  Pulmonary toxicity are due to side effects that medicinal drugs cause to the lungs.

  One year after second transplant

Study Arms (2)

Poor Risk

EXPERIMENTAL

Primary progressive, recurrent, or resistant relapse patients

Biological: filgrastim; Drug: busulfan; Drug: cyclophosphamide; Drug: etoposide; Drug: melphalan; Procedure: autologous-autologous tandem hematopoietic stem cell transplantation; Radiation: radiation therapy

Good Risk

EXPERIMENTAL

First recurrence patients

Biological: filgrastim; Drug: busulfan; Drug: cyclophosphamide; Drug: etoposide; Drug: melphalan; Procedure: autologous-autologous tandem hematopoietic stem cell transplantation; Radiation: radiation therapy

Interventions

filgrastim BIOLOGICAL

480 mcg beginning day +5

Good Risk; Poor Risk

busulfan DRUG

11.2 mg/kg; 0.8 mg/kg IV q6h X 14 doses

Good Risk; Poor Risk

cyclophosphamide DRUG

60 mg/kg IV over 2 hours x 2 days

Good Risk; Poor Risk

etoposide DRUG

60 mg/kg, IV

Good Risk; Poor Risk

melphalan DRUG

150mg/m2 in NS at a concentration of 0.4mg/cc infused over 60 minutes.

Good Risk; Poor Risk

autologous-autologous tandem hematopoietic stem cell transplantation PROCEDURE

autologous-autologous tandem hematopoietic stem cell transplantation

Good Risk; Poor Risk

radiation therapy RADIATION

radiation therapy

Good Risk; Poor Risk

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically\* confirmed Hodgkin's lymphoma meeting ≥ 1 of the following criteria: * Disease progression during initial first line chemotherapy * Complete response lasting ≤ 90 days after induction * Partial response lasting ≤ 90 days after induction * First recurrence/progression with the duration of initial response ≤ 12 months after completion of chemotherapy NOTE: \*There must be unequivocal radiological evidence of recurrent or progressive disease if biopsy was not obtained at time of disease recurrence/progression * No clonal abnormalities in marrow collection * Must have bilateral or unilateral bone marrow aspirates and biopsy within 42 days prior to stem cell collection * Must have adequate sections of original diagnostic specimen available for review * Needle aspirations or cytologies are not adequate * No prior lymphoma, myelodysplastic syndromes, or leukemia (even if disease free ≥ 5 years) * No CNS involvement PATIENT CHARACTERISTICS: Performance status * Karnofsky 50-100% Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin ≤ 1.5 times upper limit of normal\* (ULN) NOTE: \*Unless due to Hodgkin's lymphoma Renal * Creatinine clearance ≥ 60 mL/min * Creatinine ≤ 2.0 times ULN Cardiovascular * Ejection fraction ≥ 45% by 2-D echocardiogram * No significant active cardiac disease Pulmonary * Adequate pulmonary function * DLCO ≥ 45% Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer * No known HIV or AIDS infection * No active bacterial, fungal, or viral infection * No medical condition that would preclude study treatment PRIOR CONCURRENT THERAPY: Chemotherapy * See Disease Characteristics Surgery * See Disease Characteristics

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Filgrastim; Busulfan; Cyclophosphamide; Etoposide; Melphalan; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Therapeutics

Results Point of Contact

• Title: Brian Bowell, MD
• Organization: Case Comprehensive Cancer Center

bolwelb@ccf.org

216-444-6922

Study Officials

• Brian J. Bolwell, MD

  Cleveland Clinic Taussig Cancer Institute

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: December 14, 2005
• First Posted: December 15, 2005
• Study Start: February 1, 2002
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: November 20, 2013
• Results First Posted: August 26, 2013

Record last verified: 2013-10

Locations

US (1)