Combination Chemotherapy in Treating Children With Refractory or Relapsed Hodgkin's Lymphoma - Full Text View

Sponsors and Collaborators:	Children's Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00006760

Purpose

RATIONALE: Drugs used in chemotherapy, such as ifosfamide and vinorelbine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating children who have refractory or relapsed Hodgkin's lymphoma.

Condition	Intervention	Phase
Lymphoma	Biological: filgrastim Drug: ifosfamide Drug: vinorelbine ditartrate	Phase II

MedlinePlus related topics: Cancer Hodgkin's Disease Lymphoma

Drug Information available for: Vinorelbine Filgrastim Vinorelbine tartrate Ifosfamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Pilot Study of Re-Induction Chemotherapy With Ifosfamide, and Vinorelbine (IV) in Children With Refractory/Relapsed Hodgkin's Disease

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

Primary Outcome Measures:

Cardiac, hepatic, or renal toxicity [ Designated as safety issue: Yes ]
Toxic death [ Designated as safety issue: Yes ]
Hematological toxicity [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Nonhematological toxicity (grade 3 or 4) [ Designated as safety issue: Yes ]
Peripheral blood stem cell harvest [ Designated as safety issue: No ]
Response [ Designated as safety issue: No ]
Induction success [ Designated as safety issue: No ]

Study Start Date:	May 2001
Primary Completion Date:	February 2008 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the response rate (overall and within strata) in both minimally pretreated, low-risk and heavily pretreated, high-risk children with refractory or relapsed Hodgkin's lymphoma treated with ifosfamide and vinorelbine with filgrastim (G-CSF).
Determine the cardiac, hepatic, renal, and hematologic toxicity of this regimen in minimally-pretreated, low-risk patients.
Determine the toxic death rate in minimally pretreated, low-risk patients treated with this regimen.
Determine whether this treatment regimen can mobilize sufficient hematopoietic stem cells (CD34) for subsequent stem cell transplantation in minimally pretreated, low-risk patients.
Determine the incidence of hypermutability by longitudinal genotoxic biomonitoring of patients treated with this regimen.
Determine the prognostic significance of biological markers, including serum interleukin (IL)-10 receptor, serum IL-2 receptor, p53, and mdm-2 in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified by prior therapy (minimally pretreated, low-risk vs heavily pretreated, high-risk).

Patients receive ifosfamide IV over 24 hours on days 1-4 and vinorelbine IV over 6-10 minutes on days 1 and 5. Patients also receive filgrastim (G-CSF) subcutaneously or IV over 15-30 minutes beginning 24-36 hours after completion of vinorelbine and continuing daily until blood counts recover. Treatment repeats at least every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients may receive a third course of therapy at the discretion of the investigator.

Heavily pretreated, high-risk patients who achieve a complete response are eligible for stem cell transplantation. Patients undergo peripheral blood stem cell (PBSC) collection during hematopoietic recovery after the second course of chemotherapy. Patients with sufficient PBSCs collected may undergo PBSC transplantation on protocol COG-AHOD0121.

Patients are followed at 1, 6, and 12 months and then periodically thereafter.

PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study within 1.5 years.

Eligibility

Ages Eligible for Study:	up to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed refractory or relapsed Hodgkin's lymphoma
- Mixed cellularity, not otherwise specified (NOS)
- Lymphocytic depletion, NOS
- Lymphocytic depletion, diffuse fibrosis
- Lymphocytic depletion, reticular
- Lymphocytic predominance, NOS
- Lymphocytic predominance, diffuse
- Lymphocytic predominance, nodular
- Hodgkin's paragranuloma NOS
- Hodgkin's granuloma
- Hodgkin's sarcoma
- Nodular sclerosis, NOS
- Nodular sclerosis, cellular phase
- Nodular sclerosis, lymphocytic predominance
- Nodular sclerosis, mixed cellularity
- Nodular sclerosis, lymphocytic depletion
- Other (type not specified)
In first relapse
Metastasis to bone marrow with granulocytopenia, anemia, and/or thrombocytopenia allowed
Not enrolled on POG-9426 unless there is an extranodal site of recurrence

PATIENT CHARACTERISTICS:

Age:

Under 30 at diagnosis

Performance status:

Lansky 60-100% (for patients 16 years and under)
Karnofsky 60-100% (for patients over 16 years)

Life expectancy:

At least 2 months

Hematopoietic:

See Disease Characteristics
Absolute neutrophil count at least 1,000/mm^3
Platelet count at least 75,000/mm^3 (transfusion independent)

Hepatic:

Bilirubin no greater than 1.5 times normal
SGOT or SGPT less than 2.5 times normal

Renal:

Creatinine no greater than 1.5 times normal
Creatinine clearance or radioisotope glomerular filtration rate at least 70 mL/min

Cardiovascular:

Shortening fraction at least 27% by echocardiogram OR
Ejection fraction at least 50% by gated radionuclide

Other:

No other concurrent serious illness
No known hypersensitivity to E. coli-derived proteins, filgrastim (G-CSF), or any other component of study drugs

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No concurrent immunomodulating agents

Chemotherapy:

At least 2 weeks since prior chemotherapy (3 weeks for nitrosoureas) and recovered
No other concurrent anticancer chemotherapy

Endocrine therapy:

No concurrent steroids
No concurrent corticosteroids (e.g., dexamethasone)

Radiotherapy:

Recovered from prior radiotherapy

Surgery:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006760

Show 114 Study Locations

Sponsors and Collaborators

Children's Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Tanya Trippett, MD	Memorial Sloan-Kettering Cancer Center
Investigator:	Pedro A. de Alarcon, MD	St. Jude Children's Research Hospital

More Information

Additional Information:

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

No publications provided

Study ID Numbers:	CDR0000068325, COG-AHOD00P1, CCG-A5981
Study First Received:	December 6, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00006760 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

recurrent/refractory childhood Hodgkin lymphoma
childhood lymphocyte predominant Hodgkin lymphoma
childhood lymphocyte depletion Hodgkin lymphoma
childhood nodular sclerosis Hodgkin lymphoma
childhood mixed cellularity Hodgkin lymphoma

Study placed in the following topic categories:

Immunoproliferative Disorders
Hodgkin Lymphoma, Childhood
Hodgkin Lymphoma, Adult
Hodgkin's Disease
Vinblastine
Sclerosis
Antimitotic Agents
Recurrence
Lymphatic Diseases
Ifosfamide

Vinorelbine
Mechlorethamine
Tubulin Modulators
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic
Alkylating Agents
Lymphoma
Hodgkin Disease
Isophosphamide mustard

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Immunoproliferative Disorders
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Antineoplastic Agents
Mitosis Modulators
Vinblastine
Antimitotic Agents
Pharmacologic Actions
Lymphatic Diseases
Neoplasms

Ifosfamide
Vinorelbine
Therapeutic Uses
Tubulin Modulators
Antineoplastic Agents, Alkylating
Lymphoproliferative Disorders
Antineoplastic Agents, Phytogenic
Alkylating Agents
Hodgkin Disease
Lymphoma
Isophosphamide mustard

ClinicalTrials.gov processed this record on May 06, 2009