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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00669812
• Other study ID #: CDR0000593564
• Secondary ID: CRUK-2005-003906
• Status: Recruiting
• Phase: Phase 2
• First received: April 30, 2008
• Last updated: August 23, 2013
• Start date: February 2008

Study information

• Verified date: November 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Unspecified
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• Prior diagnostic or emergency surgical procedures allowed

• More than 5 years since prior treatment for malignancy

• No prior chemotherapy or radiotherapy for treatment of lymphoma

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Enteropathy-Associated T-Cell Lymphoma
• Lymphoma
• Lymphoma, T-Cell
• Small Intestine Cancer

Intervention

Drug:
• carmustine

• cyclophosphamide

• cytarabine

• doxorubicin hydrochloride

• epirubicin hydrochloride

• etoposide

• ifosfamide

• melphalan

• methotrexate

• prednisolone

• vincristine sulfate

Procedure:
• autologous hematopoietic stem cell transplantation

• biopsy

• peripheral blood stem cell transplantation

Locations

Country	Name	City	State
United Kingdom	Sir James Spence Institute of Child Health at Royal Victoria Infirmary	Newcastle-Upon-Tyne	England

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research UK

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival at 1 year			No
Secondary	Toxicity			Yes