Combination Chemotherapy Followed by Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Refractory Hodgkin's Lymphoma

NCT00002522 | Completed Phase 2

• 3 other identifiers: CDR0000078283TUHSC-2162NCI-V93-0249
• Study Type: interventional
• Target: N/A
• 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. Combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with relapsed or refractory Hodgkin's lymphoma.

Conditions

Lymphoma

Keywords

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

Interventions

cisplatin DRUG

cyclophosphamide DRUG

etoposide DRUG

autologous bone marrow transplantation PROCEDURE

bone marrow ablation with stem cell support PROCEDURE

peripheral blood stem cell transplantation PROCEDURE

syngeneic bone marrow transplantation PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically proven stage I-IV Hodgkin's lymphoma * Must have refractory or relapsed disease, defined by 1 of the following: * Failure to achieve a complete remission (CR) after 4 courses of conventional-dose front-line chemotherapy * Disease in second or greater remission * Patients should be encouraged to undergo transplantation prior to a third salvage regimen * Patients previously treated with multiple regimens considered on a case-by-case basis * No chemoresistant disease, defined as active progression with tumor growth greater than 25% by volume during first-line chemotherapy * Patients who respond to second-line chemotherapy may be eligible * Stable residual masses after conventional-dose chemotherapy not considered treatment failures * Active (refractory or relapsed) disease must be proven histologically or documented by gallium nitrate uptake * Syngeneic marrow transplantation offered to patients with consenting identical twin donor * No CNS involvement by lymphoma PATIENT CHARACTERISTICS: Age: * 15 to 60 (selected patients up to age 70 may be eligible) Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC greater than 4,000/mm\^3 * Absolute neutrophil count greater than 2,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic: * Bilirubin less than 2.0 mg/dL * SGOT and SGPT less than 2 times upper limit of normal * Albumin greater than 3.0 g/dL Renal: * Must meet 1 of the following criteria: * Creatinine less than 1.8 mg/dL * Creatinine clearance greater than 60 mL/min * BUN less than 20 mg/dL Cardiovascular: * Left ventricular ejection fraction at least 50% Pulmonary: * DLCO, FEV\_1, and FVC greater than 50% of predicted OR * Resting pO\_2 greater than 70 mm Hg on room air Other: * HIV negative * No severe neurologic or emotional disorders * No active infection * No other disease that would limit life expectancy * Not pregnant * Fertile patients must use effective contraception * Adequate psychosocial support required PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * See Disease Characteristics Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

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

Sponsors & Collaborators

• Temple University: lead

Study Sites (1)

Fox Chase - Temple Cancer Center

Philadelphia, Pennsylvania, 19111-2442, United States

Location

MeSH Terms

Conditions

Lymphoma; Hodgkin Disease

Interventions

Cisplatin; Cyclophosphamide; Etoposide; 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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Kenneth F. Mangan, MD, FACP

  Fox Chase 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

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: February 1, 1993
• Primary Completion: February 1, 2002
• Study Completion: February 1, 2002
• Last Updated: October 1, 2010

Record last verified: 2010-09

Locations

US (1)