Rituximab, Combination Chemotherapy, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Relapsed Follicular Non-Hodgkin Lymphoma

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00637832
First received: March 14, 2008
Last updated: October 6, 2009
Last verified: July 2009
  Purpose

RATIONALE: 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 work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiolabeled monoclonal antibodies, such as yttrium Y 90 ibritumomab tiuxetan, can find cancer cells and carry cancer-killing substances to them without harming normal cells. Giving rituximab together with combination chemotherapy and yttrium Y 90 ibritumomab tiuxetan may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving rituximab together with combination chemotherapy and yttrium Y 90 ibritumomab tiuxetan works in treating patients with relapsed follicular non-Hodgkin lymphoma.


Condition Intervention Phase
Lymphoma
Biological: rituximab
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: prednisolone
Drug: vincristine sulfate
Radiation: yttrium Y 90 ibritumomab tiuxetan
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: Open Label
Primary Purpose: Treatment
Official Title: Short Chemo Radiotherapy in Follicular Lymphoma Trial of 90Y Ibritumomab Tiuxetan (ZevalinTM) as Therapy for First and Second Relapse in Follicular Lymphoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall response rate, including combined complete response and partial response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression [ Designated as safety issue: No ]
  • Time to next treatment [ Designated as safety issue: No ]
  • Response duration in patients with responding disease [ Designated as safety issue: No ]
  • Safety [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: April 2008
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To evaluate the response rates in patients with relapsed follicular non-Hodgkin lymphoma treated with short-duration rituximab and combination chemotherapy (R-chemo) followed by rituximab and yttrium Y 90 ibritumomab tiuxetan.

Secondary

  • To evaluate the duration of response in patients treated with this regimen.
  • To evaluate the quality of response in order to determine the conversion rate from partial response to complete response in patients treated with this regimen.
  • To evaluate the toxicity of yttrium Y 90 ibritumomab tiuxetan when administered after 3 courses of R-chemo.

OUTLINE: This is a multicenter study.

  • Chemoimmunotherapy (R-CHOP or R-CVP): Patients receive R-CHOP comprising rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Alternatively, patients who have already been exposed to prior tolerance doses of anthracyclines receive R-CVP comprising rituximab IV, cyclophosphamide IV, and vincristine IV on day 1 and oral prednisolone on days 1-5. Treatment repeats every 3 weeks for up to 3 courses.

Patients with objective evidence of response on CT scan or those with < 25% bone marrow involvement and no signs of bone marrow hypocellularity (< 15%) on bone marrow biopsy proceed to radioimmunotherapy.

  • Radioimmunotherapy: Four to 6 weeks after completion of R-CHOP or R-CVP, patients receive rituximab IV followed no more than 4 hours later by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes.

After completion of study therapy, patients are followed periodically for up to 5 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 non-Hodgkin lymphoma

    • Stage II, III, or IV disease (according to the Ann Arbor staging system)
  • CD20-positive disease
  • Initial disease bulk ≤ 10 cm
  • In first or second relapse after prior treatment with a rituximab-containing chemotherapy regimen (R-chemo) or chemotherapy alone

    • Relapse must have occurred ≥ 6 months after completion of R-chemo

      • Relapse that occurred < 6 months after completion of chemotherapy alone allowed
  • Has at least one of the following symptoms requiring initiation of treatment:

    • Nodal mass > 5 cm in its greater diameter
    • B symptoms
    • Elevated serum lactate dehydrogenase (LDH) or β2-microglobulin
    • Involvement of ≥ 3 nodal sites (each with a diameter > 3 cm)
    • Symptomatic splenic enlargement
    • Compressive syndrome
  • No primary refractory disease
  • No large pleural or peritoneal effusions
  • No CNS disease

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 6 months
  • Absolute granulocyte count ≥ 1,500/mm³
  • Platelet count ≥ 1,000/mm³
  • Serum creatinine < 1.5 times upper limit of normal (ULN)
  • Total bilirubin < 1.5 times ULN
  • AST < 5 times ULN
  • No active obstructive hydronephrosis
  • No evidence of active infection requiring IV antibiotics
  • No advanced heart disease or other serious illness that would preclude study evaluation
  • No known HIV infection
  • No human anti-mouse antibody (HAMA) reactivity
  • No known hypersensitivity to murine antibodies or proteins
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 12 months after completion of study treatment
  • No other prior malignancy, except for adequately treated skin cancer, cervical cancer in situ, or other cancer for which the patient has been disease-free for 5 years

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 4 weeks since prior investigational drugs and recovered
  • No prior radioimmunotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00637832

Locations
United Kingdom
Christie Hospital Recruiting
Manchester, England, United Kingdom, M20 4BX
Contact: Contact Person    44-845-226-3000      
Mount Vernon Cancer Centre at Mount Vernon Hospital Recruiting
Northwood, England, United Kingdom, HA6 2RN
Contact: Contact Person    44-182-382-6111      
Dorset Cancer Centre Recruiting
Poole Dorset, England, United Kingdom, BH15 2JB
Contact: Contact Person    44-120-266-5511      
Southampton General Hospital Recruiting
Southampton, England, United Kingdom, SO16 6YD
Contact: Contact Person    44-238-079-8934    kc8@soton.ac.uk   
Saint Bartholomew's Hospital Recruiting
London, United Kingdom, EC1A 7BE
Contact: Contact Person    44-207-377-7000      
Sponsors and Collaborators
University Hospital Southampton NHS Foundation Trust.
Investigators
Principal Investigator: Tim Illidge Christie Hospital NHS Foundation Trust
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00637832     History of Changes
Other Study ID Numbers: CDR0000588042, USCTU-SCHRIFT-06-DOG05-44, USCTU-SCHRIFT, USCTU-RHM-CAN0542, EUDRACT 2007-000222-51, EU-20819
Study First Received: March 14, 2008
Last Updated: October 6, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent grade 1 follicular lymphoma
recurrent grade 2 follicular lymphoma
recurrent grade 3 follicular lymphoma
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, Follicular
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Rituximab
Doxorubicin
Prednisolone
Methylprednisolone Hemisuccinate
Vincristine
Antibodies, Monoclonal
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014