Iodine I 131 Tositumomab, Rituximab, and Combination Chemotherapy in Treating Patients With Previously Untreated Stage II, Stage III, or Stage IV Follicular Non-Hodgkin Lymphoma - Full Text View

Sponsor:	Southwest Oncology Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00770224

Purpose

RATIONALE: Radiolabeled monoclonal antibodies, such as iodine I 131 tositumomab, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, vincristine, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving a radiolabeled monoclonal antibody together with rituximab and combination chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying the side effects of giving iodine I 131 tositumomab together with rituximab and combination chemotherapy and to see how well it works in treating patients with previously untreated stage II, stage III, or stage IV follicular non-Hodgkin lymphoma.

Condition	Intervention	Phase
Lymphoma	Biological: rituximab Biological: tositumomab Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: prednisone Drug: vincristine sulfate Radiation: iodine I 131 tositumomab	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	A Phase II Study of Iodine-131-Labeled Tositumomab in Combination With Cyclophosphamide, Doxorubicin, Vincristine, Prednisone and Rituximab Therapy for Patients With Advanced Stage Follicular Non-Hodgkin's Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Cyclophosphamide Prednisone Vincristine Doxorubicin Doxorubicin hydrochloride Cadexomer iodine Rituximab Tositumomab Vincristine sulfate Iodine Sodium iodide I 131

U.S. FDA Resources

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

Primary Outcome Measures:

3-year progression-free survival (PFS) [ Designated as safety issue: No ]

Secondary Outcome Measures:

5-year PFS [ Designated as safety issue: No ]
5-year overall survival [ Designated as safety issue: No ]
Response [ Designated as safety issue: No ]
Safety profile as assessed by NCI CTCAE v3.0

Estimated Enrollment:	80
Study Start Date:	September 2008
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

To evaluate the response rate in patients with previously untreated stage II-IV follicular non-Hodgkin lymphoma treated with rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (R-CHOP) in combination with iodine I 131 tositumomab.
To evaluate the toxicity of this regimen in these patients.
To estimate the 3-year progression-free survival rate in patients treated with this regimen.
To estimate the 5-year progression-free and overall survival rate in patients treated with this regimen.
To assess the safety profile of this regimen in these patients.

OUTLINE: This is a multicenter study.

Induction therapy: Patients receive R-CHOP* comprising rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with at least stable disease then proceed to consolidation therapy.

NOTE: *Patients receive R-CHOP in courses 1-4 and CHOP alone in courses 5 and 6.

Consolidation therapy: Within 12 weeks after completion of induction therapy, patients receive tositumomab IV over 1 hour followed by a dosimetric dose of iodine I 131 tositumomab IV over 20 minutes. Patients then undergo whole body gamma camera scans over a 1-week period to determine the rate of total body clearance of radioactivity and the therapeutic dose of iodine I 131 tositumomab. Within 7-14 days after the dosimetric dose, patients receive tositumomab IV over 1 hour followed by a therapeutic dose of iodine I 131 tositumomab IV over 20 minutes. Patients with at least stable disease then proceed to maintenance therapy.
Maintenance therapy: Beginning approximately 1 year after study entry and no more than 28 days after restaging, patients receive rituximab IV every 3 months for up to 4 years (16 courses) in the absence of disease progression or unacceptable toxicity.

After completion of maintenance therapy, patients are followed annually for up to 7 years. Patients who do not complete maintenance therapy are followed every 6 months for 2 years and then annually for up to 7 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed* grade 1, 2, or 3 follicular B-cell non-Hodgkin lymphoma meeting the following criteria:
- Bulky stage II or stage III or IV disease
- Diffuse large cell component must be < 25% of the biopsy
- Confirmed CD20 antigen-positive disease NOTE: *Needle aspiration or cytology are not considered adequate for pathology review
Patient must have unilateral or bilateral bone marrow aspirate and biopsy performed within 42 days
- Positive biopsy performed > 42 days but < 6 months allowed
Previously untreated disease
Bidimensionally measurable disease
No clinical evidence of CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

Zubrod performance status 0-2
Cardiac ejection fraction ≥ 45% by MUGA or ECHO
No significant cardiac abnormalities
No known HIV positivity
No requirement for continuous supplemental oxygen therapy
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer from which the patient is currently in complete remission
Not pregnant or nursing
Fertile patients must use effective contraception during and for 12 months after completion of maintenance therapy

PRIOR CONCURRENT THERAPY:

No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma
No prior solid organ transplantation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770224

Show 111 Study Locations

Sponsors and Collaborators

Southwest Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:	Jonathan W. Friedberg, MD	James P. Wilmot Cancer Center
Investigator:	Oliver W. Press, MD, PhD	Fred Hutchinson Cancer Research Center
Investigator:	Lisa Rimsza, MD	University of Arizona

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

Responsible Party:	Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker )
Study ID Numbers:	CDR0000615104, SWOG-S0801
Study First Received:	October 8, 2008
Last Updated:	February 4, 2010
ClinicalTrials.gov Identifier:	NCT00770224 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

contiguous stage II grade 1 follicular lymphoma
contiguous stage II grade 2 follicular lymphoma
contiguous stage II grade 3 follicular lymphoma
noncontiguous stage II grade 1 follicular lymphoma
noncontiguous stage II grade 2 follicular lymphoma
noncontiguous stage II grade 3 follicular lymphoma

stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Follicular
Anti-Inflammatory Agents
Anti-Infective Agents
Prednisone
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Iodine-131 anti-B1 antibody
Cyclophosphamide
Antibiotics, Antineoplastic
Hormones

Antibodies, Monoclonal
Therapeutic Uses
Iodine
Micronutrients
Alkylating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Rituximab
Growth Substances
Mitosis Modulators
Vincristine
Trace Elements
Antimitotic Agents

ClinicalTrials.gov processed this record on February 08, 2010