Chemotherapy Plus Radiation Therapy in Treating Patients With Refractory or Relapsed Hodgkin's Lymphoma

NCT00003631 | Completed Phase 2 Results

• 3 other identifiers: 98-071CDR0000066714NCI-G98-1480
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy and radiation therapy used to kill tumor cells. PURPOSE: Phase II trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients with refractory or relapsed Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

recurrent adult Hodgkin lymphoma; recurrent/refractory childhood Hodgkin lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective Response

  Determine the overall objective response. CR rate \[as measured from the start of ICE, (or high dose CTX) to the end of transplant for those who receive it, or the end of ICE for those who do not\].Complete response (CR): No evidence of Hodgkin's disease determined clinically, radiologically or pathologically when indicated

  2 years

Study Arms (3)

Arm I

EXPERIMENTAL

(0-1 adverse prognostic factors): Patients receive ifosfamide by 24 hour infusion on day 2. Carboplatin is administered on day 2. Etoposide IV is administered once daily on days 1-3. Patients then receive filgrastim (G-CSF) subcutaneously or IV on days 5-12. Patients receive another course of ICE chemotherapy 2-3 weeks after the first course.

Biological: filgrastim

Arm II

EXPERIMENTAL

(2 adverse prognostic factors): Patients receive the first course of ICE as in Arm I

Biological: filgrastim

Arm III

EXPERIMENTAL

Arm III (3 adverse prognostic factors): Patients receive cyclophosphamide IV daily for 2 days, then G-CSF beginning on day 4 until blood stem cells are collected

Biological: filgrastim; Drug: carboplatin; Drug: carmustine; Drug: cyclophosphamide; Drug: cytarabine; Drug: etoposide; Drug: ifosfamide; Drug: melphalan; Procedure: bone marrow ablation with stem cell support; Procedure: peripheral blood stem cell transplantation; Radiation: radiation therapy

Interventions

filgrastim BIOLOGICAL

Arm I; Arm II; Arm III

carboplatin DRUG

Arm III

carmustine DRUG

Arm III

cyclophosphamide DRUG

Arm III

cytarabine DRUG

Arm III

etoposide DRUG

Arm III

ifosfamide DRUG

Arm III

melphalan DRUG

Arm III

bone marrow ablation with stem cell support PROCEDURE

Arm III

peripheral blood stem cell transplantation PROCEDURE

Arm III

radiation therapy RADIATION

Arm III

Eligibility Criteria

• Age: Up to 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed residual or relapsed Hodgkin's lymphoma following conventional dose standard chemotherapy * Presence of the following prognostic factors are allowed: * B symptoms (fever, weight loss, night sweats) * Extranodal disease * Complete remission of less than 1 year duration PATIENT CHARACTERISTICS: Age: * Not specified Performance status: * Not specified Life expectancy: * Not specified Hematopoietic: * Not specified Hepatic: * Bilirubin less than 2.0 mg/dL unless history of Gilbert's disease * No chronic active or persistent hepatitis Renal: * No history of chronic renal insufficiency * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No myocardial infarction within the past 6 months * No unstable angina * No significant cardiac arrhythmias other than chronic atrial fibrillation * Ejection fraction at least 50% Pulmonary: * DLCO at least 50% Other: * No uncontrolled infection * HIV negative * At least 5 years since prior malignancy except: * Curatively treated cutaneous basal cell carcinoma * Carcinoma in situ of the cervix * Not pregnant or nursing * Fertile women must use effective contraception PRIOR CONCURRENT THERAPY: * Must have failed conventional dose standard chemotherapy

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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease; Recurrence

Interventions

Filgrastim; Carboplatin; Carmustine; Cyclophosphamide; Cytarabine; Etoposide; Ifosfamide; Melphalan; Peripheral Blood Stem Cell Transplantation; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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; Coordination Complexes; Organic Chemicals; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Oxazines; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Joachim Yahalom
• Organization: Memorial Sloan Kettering Cancer Center

yahalomj@mskcc.org

1212-639-5999

Study Officials

• Joachim Yahalom, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

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: November 1, 1999
• First Posted: January 27, 2003
• Study Start: August 1, 1998
• Primary Completion: April 1, 2010
• Last Updated: January 25, 2016
• Results First Posted: January 25, 2016

Record last verified: 2015-12

Locations

US (1)