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Rituximab, Prednisone, Cyclophosphamide, Doxorubicin, Vincristine, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Previously Untreated Mantle Cell Lymphoma
This study is ongoing, but not recruiting participants.
First Received: October 3, 2003   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00070447
  Purpose

RATIONALE: Monoclonal antibodies, such as rituximab and yttrium Y 90 ibritumomab tiuxetan, can locate cancer cells and either kill them or deliver radioactive cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as prednisone, cyclophosphamide, doxorubicin, and vincristine, use different ways to stop cancer cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab and combination chemotherapy together with yttrium Y 90 ibritumomab tiuxetan works in treating patients with previously untreated mantle cell lymphoma.


Condition Intervention Phase
Lymphoma
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisone
Drug: vincristine sulfate
Radiation: yttrium Y 90 ibritumomab tiuxetan
Phase II

MedlinePlus related topics: Cancer Lymphoma
Drug Information available for: Cyclophosphamide Prednisone Vincristine Doxorubicin Doxorubicin hydrochloride Myocet Rituximab Ibritumomab tiuxetan Vincristine sulfate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Study of Rituximab (NSC 687451) + CHOP Followed by 90Y-Ibritumomab Tiuxetan (NSC 710085) in Patients With Previously Untreated Mantle Cell Lymphoma

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

Study Start Date: November 2003
Detailed Description:

OBJECTIVES:

  • Determine the time to treatment failure in patients with previously untreated mantle cell lymphoma treated with rituximab and CHOP chemotherapy comprising prednisone, cyclophosphamide, doxorubicin, and vincristine followed by yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8; yttrium Y 90 Zevalin®).
  • Determine the response rate in patients at the completion of rituximab and CHOP and the incremental response rate after IDEC-Y2B8.
  • Determine the toxicity of this regimen in these patients.
  • Correlate serum rituximab levels with response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

  • CHOP chemotherapy and rituximab: Patients receive cyclophosphamide IV, doxorubicin IV, vincristine IV, and rituximab IV on day 1 and oral prednisone on days 1-5 (R + CHOP). Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients who have responding or stable disease proceed to radioimmunotherapy.

  • Radioimmunotherapy: Within 4-7 weeks after the completion of R + CHOP chemotherapy, patients receive rituximab IV and an imaging dose of indium In 111 ibritumomab tiuxetan IV over 10 minutes on day 1. Patients then undergo whole body gamma imaging scans during the first day (2-24 hours) and the second or third day (48-72 hours) after injection. In the absence of altered biodistribution, patients receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan (IDEC-Y2B8; yttrium Y 90 Zevalin®) IV over 10 minutes on day 8.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.

PROJECTED ACCRUAL: A total of 57 patients will be accrued for this study within 2.8 years.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically confirmed mantle cell lymphoma with expression of bcl-1 and CD20

    • Stage II-IV disease
  • Measurable or evaluable disease

    • Measurable disease defined as at least 1 bidimensionally measurable lesion at least 2 cm by imaging scan
    • A spleen at least 17 cm or having discrete filling defects by CT scan will constitute evaluable disease provided that no explanation other than lymphomatous involvement (e.g., portal hypertension or other liver disease) is likely
  • No known CNS lymphoma

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 6 months

Hematopoietic

  • WBC greater than 2,500/mm^3*
  • Platelet count greater than 100,000/mm^3* NOTE: *Unless due to disease in bone marrow

Hepatic

  • Bilirubin less than 1.5 mg/dL (1.5-3.0 mg/dL if due to liver involvement by lymphoma)
  • ALT and AST no greater than 2.5 times upper limit of normal (unless due to liver involvement by lymphoma)

Renal

  • Creatinine less than 2.0 mg/dL
  • Calcium no greater than 11.5 mg/dL

Cardiovascular

  • LVEF greater than 45%

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 1 year after study participation
  • HIV negative
  • No other malignancy except treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer or any other surgically cured malignancy from which the patient has been disease-free for at least 3 years
  • No other concurrent serious medical condition or active infection that would preclude ability to deliver standard prednisone, cyclophosphamide, doxorubicin, and vincristine (CHOP) chemotherapy

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior immunotherapy

Chemotherapy

  • No prior chemotherapy

Endocrine therapy

  • Prior corticosteroids allowed provided the course was no more than 2 weeks in duration

Radiotherapy

  • No prior radiotherapy

Surgery

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00070447

  Show 87 Study Locations
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Mitchell R. Smith, MD, PhD Fox Chase Cancer Center
Investigator: Leo I. Gordon, MD Robert H. Lurie Cancer Center
  More Information

Additional Information:
Publications:
Smith MR, Zhang L, Gordon LI, et al.: Phase II study of R-CHOP followed by 90Y-ibritumomab tiuxetan in untreated mantle cell lymphoma: Eastern Cooperative Oncology Group study E1499. [Abstract] Blood 110 (11): A-389, 2007.
Smith MR, Chen H, Gordon L, et al.: Phase II study of rituximab + CHOP followed by 90Y-ibritumomab tiuxetan in patients with previously untreated mantle cell lymphoma: an Eastern Cooperative Oncology Group Study (E1499). [Abstract] J Clin Oncol 24 (Suppl 18): A-7503, 422s, 2006.

Study ID Numbers: CDR0000334470, ECOG-E1499
Study First Received: October 3, 2003
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00070447     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
contiguous stage II mantle cell lymphoma
noncontiguous stage II mantle cell lymphoma
stage III mantle cell lymphoma
stage IV mantle cell lymphoma

Study placed in the following topic categories:
Anti-Inflammatory Agents
Prednisone
Immunologic Factors
Lymphoma, Mantle-Cell
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mantle Cell Lymphoma
Cyclophosphamide
Hormones
Antibodies, Monoclonal
Anti-Bacterial Agents
Lymphoma
Alkylating Agents
Immunoglobulins
Immunoproliferative Disorders
Antineoplastic Agents, Hormonal
Rituximab
Vincristine
Antimitotic Agents
Immunosuppressive Agents
Glucocorticoids
Doxorubicin
Lymphatic Diseases
Antibodies
Tubulin Modulators
Antineoplastic Agents, Alkylating
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Prednisone
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Lymphoma, Mantle-Cell
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Cyclophosphamide
Antibiotics, Antineoplastic
Hormones
Antibodies, Monoclonal
Therapeutic Uses
Lymphoma
Alkylating Agents
Immunoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Immune System Diseases
Rituximab
Mitosis Modulators
Vincristine
Antimitotic Agents
Glucocorticoids
Immunosuppressive Agents
Doxorubicin
Pharmacologic Actions
Lymphatic Diseases
Neoplasms
Tubulin Modulators

ClinicalTrials.gov processed this record on May 07, 2009