Combination Chemotherapy and Radiation Therapy in Treating Patients Who Are Undergoing an Autologous Stem Cell Transplant for Relapsed or Refractory Hodgkin's Lymphoma - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00255723

Purpose

RATIONALE: Drugs used in chemotherapy 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. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving combination chemotherapy and radiation therapy with an autologous stem cell transplant, using peripheral stem cells or bone marrow from the patient, may allow more chemotherapy to be given so that more cancer cells are killed. Giving combination chemotherapy together with radiation therapy before an autologous stem cell transplant may be an effective treatment for Hodgkin's lymphoma.

PURPOSE: This phase II trial is studying how well combination chemotherapy and radiation therapy work in treating patients who are undergoing an autologous stem cell transplant for relapsed or refractory Hodgkin's lymphoma.

Condition	Intervention	Phase
Lymphoma	Drug: carboplatin Drug: etoposide Drug: ifosfamide	Phase II

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma

Drug Information available for: Ifosfamide Carboplatin Etoposide Etoposide phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Risk-Adapted High Dose Chemoradiotherapy and Autologous Stem Cell Transplantation for Patients With Relapsed and Primary Refractory Hodgkin's Lymphoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Event-free survival at 3 years [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	April 2004
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cytoreductive chemotherapy group 1: Experimental Patients receive ICE comprising ifosfamide IV and carboplatin IV once on day 2 and etoposide IV over 1 hour once daily on days 1-3. Patients then receive ifosfamide IV twice on day 15, carboplatin IV once on day 17 and etoposide IV over 1 hour twice daily on days 15-17.	Drug: carboplatin Given IV Drug: etoposide Given IV Drug: ifosfamide Given IV
Cytoreductive chemotherapy group 2: Experimental Patients receive ifosfamide IV twice on days 1 and 17, carboplatin IV once on days 3 and 19, and etoposide IV over 1 hour twice daily on days 1-3 and 17-19.	Drug: carboplatin Given IV Drug: etoposide Given IV Drug: ifosfamide Given IV

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 72 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed Hodgkin's lymphoma
- Refractory or relapsed disease by biopsy or fine-needle aspiration
- No lymphocyte-predominant histology
Must have failed front-line therapy comprising doxorubicin or carmustine
Evidence of positron emission tomography (PET)-avid disease
Must have ≤ 2 of the following risk factors:
- Extranodal sites of disease
- Initial response duration < 1 year
- Presence of B symptoms

PATIENT CHARACTERISTICS:

Performance status

Not specified

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count > 1,000/mm^3
Platelet count > 50,000/mm^3

Hepatic

Bilirubin ≤ 2.0 mg/dL (unless Gilbert's disease is present)
Hepatitis B surface antigen negative

Renal

Creatinine ≤ 1.5 mg/dL OR
Creatinine clearance > 60 mL/min

Cardiovascular

Ejection fraction > 45%

Pulmonary

DLCO > 50%

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No other unrelated medical illness that would preclude study treatment
HIV I and II negative
No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Chemotherapy

See Disease Characteristics
No prior carboplatin, cisplatin, ifosfamide, gemcitabine hydrochloride, or vinorelbine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00255723

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10021
Contact: Craig Moskowitz, MD 212-639-2696 moskowic@mskcc.org

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Craig Moskowitz, MD

Memorial Sloan-Kettering Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Craig Moskowitz )
Study ID Numbers:	CDR0000449960, MSKCC-04047
Study First Received:	November 18, 2005
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00255723
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

adult lymphocyte depletion Hodgkin lymphoma
adult mixed cellularity Hodgkin lymphoma
adult nodular sclerosis Hodgkin lymphoma
recurrent adult Hodgkin lymphoma

Study placed in the following topic categories:

Immunoproliferative Disorders
Hodgkin's disease
Hodgkin lymphoma, adult
Sclerosis
Carboplatin
Etoposide phosphate
Recurrence

Lymphatic Diseases
Ifosfamide
Lymphoproliferative Disorders
Lymphoma
Hodgkin Disease
Etoposide
Isophosphamide mustard

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents

Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009