High-Dose Chemotherapy Given Together With Peripheral Blood Stem Cell Transplant in Treating Patients With Intestinal T-Cell Lymphoma

Sponsor

Cancer Research UK (Other)

Overall Status

Unknown status

CT.gov ID

NCT00669812

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

Brief Summary

RATIONALE: Giving chemotherapy before a peripheral blood stem cell transplant stops the growth of cancer cells by stopping them from dividing or by killing them. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy.

PURPOSE: This phase II trial is studying high-dose chemotherapy given together with peripheral blood stem cell transplant in treating patients with intestinal T-cell lymphoma.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma Small Intestine Cancer	Drug: carmustine Drug: cyclophosphamide Drug: cytarabine Drug: doxorubicin hydrochloride Drug: epirubicin hydrochloride Drug: etoposide Drug: ifosfamide Drug: melphalan Drug: methotrexate Drug: prednisolone Drug: vincristine sulfate Procedure: autologous hematopoietic stem cell transplantation Procedure: biopsy Procedure: peripheral blood stem cell transplantation	Phase 2

Detailed Description

OBJECTIVES:

Primary

To assess the efficacy and toxicity of intensive high-dose chemotherapy (alternating I'VE regimen and intermediate-dose methotrexate) followed by autologous peripheral blood stem cell transplantation for treatment of patients with intestinal T-cell lymphoma.

Secondary

To assess the toxicity of the regimen in a large population of these patients.
To provide a coordinated approach to the treatment of these patients.
To register patients unfit for the protocol chemotherapy into the pathological part of the study.

OUTLINE: This is a multicenter study

Chemotherapy: Patients receive CHOP chemotherapy comprising cyclophosphamide IV over 15 minutes, doxorubicin hydrochloride IV, and vincristine IV on day 1. Patients also receive oral prednisolone on days 1-5.

After recovering from CHOP chemotherapy, patients receive I'VE chemotherapy comprising epirubicin hydrochloride IV on day 1 and etoposide IV over 2 hours and ifosfamide IV continuously on days 21-23. Patients also receive methotrexate IV over 24 hours on day 21. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Consolidation therapy: On day 77, stem cells are collected from patients if the marrow is clear of disease. After completion of chemotherapy, patients in complete remission receive carmustine IV on day 105, cytarabine IV and etoposide IV on days 106-109, and melphalan IV on day 110. These patients undergo autologous peripheral blood stem cell transplantation on day 112.

Prior to study treatment, patients undergo a biopsy of the gut to confirm diagnosis and a blood sample is taken. Both blood and tissue samples may be used for further studies.

After recovery from treatment, patients are followed monthly for 4 months, then bimonthly for 1 year, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 1 year, and then annually thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Evaluation of High Dose Chemotherapy and Autologous Stem Cell Transplantation for Intestinal T-cell Lymphomas

Study Start Date :

Feb 1, 2008

Outcome Measures

Primary Outcome Measures

Survival at 1 year []

Secondary Outcome Measures

Toxicity []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Newly confirmed diagnosis of intestinal T-cell lymphoma/ enteropathy-type T-cell lymphoma according to the following WHO classifications:
Usual phenotype CD3-, CD7-positive; CD5-, CD4-, CD8-negative; or CD30-positive
Complete surgical resection allowed

PATIENT CHARACTERISTICS:

Unsupported neutrophils ≥ 1,500/mm^3 unless attributed to lymphomatous bone marrow infiltration
Unsupported platelets ≥ 100,000/mm^3 unless attributed to lymphomatous bone marrow infiltration
Creatinine clearance ≥ 50 mL/min
Alkaline phosphatase ≤ 2.5 times upper limit of normal (ULN)
Bilirubin ≤ 2.5 times ULN
Left ventricular ejection fraction ≥ 50%
Not pregnant or nursing
Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment
Patients with any serious concomitant medical or psychiatric condition that would preclude them tolerating the planned treatment should be entered into the registration study only
No known hepatitis B, hepatitis C, or HIV positivity
No active uncontrolled cardiovascular disease
No abnormal EKG if there is a previous history of cardiac problems
No other severe impairment of cardiac function
No active malignancy within the past 5 years except cervical intraepithelial neoplasia or localized skin cancer