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Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Precancerous Condition

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Trial Information

Phase I/II Trial of Omega-3 Fatty Acids for Cancer Cachexia


OBJECTIVES:

- Determine whether omega-3 fatty acids will reverse weight loss in advanced cancer
patients with cachexia.

- Determine the maximum tolerated dose (MTD) of omega-3 fatty acids in these patients
(phase I completed 12/1999).

- Determine whether omega-3 fatty acids will result in an antitumor response.

OUTLINE: This is a randomized, stratified, dose escalation study. Patients are stratified by
the extent of weight loss (2-5 percent or greater than 5 percent in the past month).

Patients receive omega-3 fatty acids orally in two equal doses with/after breakfast and
lunch for 4 months or until weight loss is observed.

Dose is escalated in cohorts of two patients, although dose escalation is allowed in
individual patients. The maximum tolerated dose (MTD) is defined as the highest dose level
at which no greater than one-third of the patients treated, including escalated patients
from a lower dose, experience grade 3 or worse toxicity (phase I completed 12/1999).

Patients are evaluated for cachexia response every 2 weeks, and tumor response every 4 weeks
for a maximum of 4 months. If no response of cachexia or tumor after a 2 month period,
patients will be discontinued from study. Patients will be followed for survival
post-treatment.

PROJECTED ACCRUAL: A total of 57-63 patients will be enrolled in the Phase I and II study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically proven advanced cancer not amenable to curative
therapy (solid tumors and hematologic malignancies eligible except primary and
metastatic brain tumors)

- Cachexia (weight loss at least 2 percent within a one month period)

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance Status:

- CALBG 0-2

Life Expectancy:

- At least 2 months

Hematopoietic:

- Granulocytes greater than 1,000/mm3

- Platelet count greater than 75,000/mm3

- Hemoglobin greater than 8 mg/dL

Hepatic:

- AST less than 3 times upper limit of normal (ULN)

- Alkaline phosphatase less than 3 times ULN

- Bilirubin less than 1.5 times ULN

Renal:

- BUN less than 1.5 times ULN

- Creatinine less than 1.5 times ULN

Cardiovascular:

- No congestive heart failure requiring diuretics within less than 6 months

- No uncontrolled or severe cardiovascular disease within less than 6 months

- No myocardial infarction within less than 6 months

Other:

- Not pregnant nor contemplating pregnancy during study

- Negative pregnancy test

- No uncontrolled hypercalcemia

- No metabolic disorders (hyperthyroidism)

- No poorly controlled diabetes

- No peripheral edema or ascites requiring diuretics

- No enteric fistulas, with tracheobronchial fistulas or with aspiration

- No esophageal or bowel obstruction that would preclude eating

- Free T4 within normal range

- No serious medical illness

- No psychosis

- No uncontrolled bacterial, viral, or fungal infections

- No active uncontrolled duodenal ulcers

- Above laboratory values required unless bone marrow, liver, kidney, or splenic
involvement by tumor is documented

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- Prior and concurrent chemotherapy allowed

Endocrine therapy:

- No concurrent steroids such as dronabinol or megestrol acetate (except for adrenal
failure)

Radiotherapy:

- No prior or concurrent radiotherapy to abdomen or pelvis

Surgery:

- Greater than 3 weeks since major surgery

- Greater than 1 week since minor surgery

Other:

- No concurrent diuretics

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

C. Patrick Burns, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Holden Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000065766

NCT ID:

NCT00003077

Start Date:

October 1995

Completion Date:

Related Keywords:

  • Leukemia
  • Lymphoma
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Precancerous Condition
  • stage III adult Hodgkin lymphoma
  • stage IV adult Hodgkin lymphoma
  • monoclonal gammopathy of undetermined significance
  • recurrent adult Hodgkin lymphoma
  • isolated plasmacytoma of bone
  • extramedullary plasmacytoma
  • refractory multiple myeloma
  • Waldenström macroglobulinemia
  • stage III multiple myeloma
  • stage III chronic lymphocytic leukemia
  • stage IV chronic lymphocytic leukemia
  • recurrent adult acute myeloid leukemia
  • recurrent adult acute lymphoblastic leukemia
  • relapsing chronic myelogenous leukemia
  • refractory chronic lymphocytic leukemia
  • chronic phase chronic myelogenous leukemia
  • accelerated phase chronic myelogenous leukemia
  • blastic phase chronic myelogenous leukemia
  • meningeal chronic myelogenous leukemia
  • untreated adult acute lymphoblastic leukemia
  • untreated adult acute myeloid leukemia
  • adult acute myeloid leukemia in remission
  • adult acute lymphoblastic leukemia in remission
  • untreated hairy cell leukemia
  • progressive hairy cell leukemia, initial treatment
  • refractory hairy cell leukemia
  • chronic myelomonocytic leukemia
  • T-cell large granular lymphocyte leukemia
  • acute undifferentiated leukemia
  • stage III grade 1 follicular lymphoma
  • stage III grade 2 follicular lymphoma
  • stage III grade 3 follicular lymphoma
  • stage III adult diffuse small cleaved cell lymphoma
  • stage III adult diffuse mixed cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • stage III adult immunoblastic large cell lymphoma
  • stage III adult lymphoblastic lymphoma
  • stage III adult Burkitt lymphoma
  • stage IV grade 1 follicular lymphoma
  • stage IV grade 2 follicular lymphoma
  • stage IV grade 3 follicular lymphoma
  • stage IV adult diffuse small cleaved cell lymphoma
  • stage IV adult diffuse mixed cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • stage IV adult immunoblastic large cell lymphoma
  • stage IV adult lymphoblastic lymphoma
  • stage IV adult Burkitt 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 lymphoblastic lymphoma
  • recurrent adult Burkitt lymphoma
  • stage III adult T-cell leukemia/lymphoma
  • stage IV adult T-cell leukemia/lymphoma
  • recurrent adult T-cell leukemia/lymphoma
  • secondary acute myeloid leukemia
  • prolymphocytic leukemia
  • AIDS-related peripheral/systemic lymphoma
  • AIDS-related primary CNS lymphoma
  • stage III small lymphocytic lymphoma
  • stage III mantle cell lymphoma
  • stage IV mantle cell lymphoma
  • recurrent small lymphocytic lymphoma
  • recurrent mantle cell lymphoma
  • angioimmunoblastic T-cell lymphoma
  • anaplastic large cell lymphoma
  • stage IV small lymphocytic lymphoma
  • stage IV marginal zone lymphoma
  • stage III marginal zone lymphoma
  • recurrent marginal zone lymphoma
  • extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
  • nodal marginal zone B-cell lymphoma
  • splenic marginal zone lymphoma
  • Neoplasms
  • Leukemia
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma
  • Precancerous Conditions
  • Lymphoma, Large-Cell, Immunoblastic

Name

Location

CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
New York Presbyterian Hospital - Cornell CampusNew York, New York  10021
Holden Comprehensive Cancer Center at The University of IowaIowa City, Iowa  52242-1009
North Shore University HospitalManhasset, New York  11030