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A Phase II Trial of Ifosfamide, Carboplatin, and Etoposide (ICE) Chemotherapy in Combination With Rituximab as Salvage Therapy


Phase 2
19 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

A Phase II Trial of Ifosfamide, Carboplatin, and Etoposide (ICE) Chemotherapy in Combination With Rituximab as Salvage Therapy


OBJECTIVES:

- Determine the chemosensitivity rate in patients with recurrent or refractory
non-Hodgkin's lymphoma treated with ifosfamide, carboplatin, and etoposide (ICE) in
combination with rituximab.

- Determine whether the addition of rituximab changes the toxicity profile of the ICE
chemotherapy regimen in these patients.

OUTLINE: Patients receive rituximab IV on days 1, 8, and 15 and ifosfamide IV over 1 hour,
etoposide IV over 2 hours, and carboplatin IV on days 2-4. Treatment continues every 21 days
for 2 courses in the absence of disease progression or unacceptable toxicity. Patients who
are not candidates for autologous stem cell transplantation may receive 1-4 more courses of
chemotherapy without rituximab.

Patients are followed at 1 month.

PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study within 2 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed recurrent or refractory B-cell non-Hodgkin's lymphoma

- CD20 positive

- Bidimensionally measurable or evaluable disease

- No myelodysplastic syndrome or chronic myeloid leukemia

PATIENT CHARACTERISTICS:

Age:

- 19 and over

Performance status:

- ECOG 0-2 OR

- Karnofsky 70-100%

Life expectancy:

- At least 3 months

Hematopoietic:

- WBC at least 3,000/mm3

- Granulocyte count at least 1,000/mm3

- Platelet count at least 100,000/mm3

Hepatic:

- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST or ALT no greater than 2.5 times ULN

Renal:

- Creatinine no greater than 1.5 mg/dL

Other:

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other prior malignancy except curatively treated basal cell carcinoma, squamous
cell carcinoma, or carcinoma in situ of the cervix

- No active serious infection

- No other concurrent serious medical condition that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior bone marrow or peripheral blood stem cell transplantation for non-Hodgkin's
lymphoma

Chemotherapy:

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent corticosteroids except transient administration as antiemetic

- Concurrent non-steroidal hormonal therapy allowed for non-disease related conditions
(e.g., insulin for diabetes)

Radiotherapy:

- No concurrent radiotherapy

Surgery:

- Not specified

Other:

- No other concurrent investigational therapy

- No other concurrent antitumor agents

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Julie M. Vose, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Nebraska

Authority:

United States: Federal Government

Study ID:

032-00

NCT ID:

NCT00007865

Start Date:

September 2000

Completion Date:

April 2008

Related Keywords:

  • Lymphoma
  • recurrent grade 1 follicular lymphoma
  • recurrent grade 2 follicular lymphoma
  • recurrent grade 3 follicular lymphoma
  • recurrent adult diffuse small cleaved cell lymphoma
  • recurrent adult diffuse mixed cell lymphoma
  • recurrent adult diffuse large cell lymphoma
  • recurrent adult immunoblastic large cell lymphoma
  • recurrent adult Burkitt lymphoma
  • recurrent mantle cell lymphoma
  • recurrent marginal zone lymphoma
  • recurrent small lymphocytic lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin

Name

Location

UNMC Eppley Cancer Center at the University of Nebraska Medical CenterOmaha, Nebraska  68198-7680