RATIONALE: Omega-3 fatty acids are used by the body for energy and tissue development and may be an effective treatment for patients with advanced cancer who are unable to maintain their body weight. PURPOSE: Phase I/II trial to study the effectiveness of omega-3 fatty acids in treating patients with advanced cancer who have significant weight loss.

Condition	Treatment or Intervention	Phase
Leukemia Lymphoma Multiple Myeloma	Procedure: supportive care  Drug: nutritional support  Procedure: anticachectic therapy  Behavior: supportive care/therapy  Drug: omega-3 fatty acids	Phase I Phase II

Further Study Details: 

OBJECTIVES: I. Determine whether omega-3 fatty acids will reverse weight loss in advanced cancer patients with cachexia. II. Determine the maximum tolerated dose (MTD) of omega-3 fatty acids in these patients (phase I completed 12/1999). III. Determine whether omega-3 fatty acids will result in an antitumor response.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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)

--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

--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

Delaware
      CCOP - Christiana Care Health Services, Wilmington,  Delaware,  19899,  United States
Iowa
      Holden Comprehensive Cancer Center at The University of Iowa, Iowa City,  Iowa,  52242-1009,  United States
New York
      New York Presbyterian Hospital - Cornell Campus, New York,  New York,  10021,  United States
      North Shore University Hospital, Manhasset,  New York,  11030,  United States
North Carolina
      CCOP - Southeast Cancer Control Consortium, Winston Salem,  North Carolina,  27104-4241,  United States

Study chairs or principal investigators

C. Patrick Burns,  Study Chair,  Cancer and Leukemia Group B   

Study ID Numbers:  CDR0000065766; CLB-9473; NCI-P97-0097
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003077
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08