This early phase I trial tests the safety and side effects of ruxolitinib for treating cancer cachexia in patients with stage IV lung cancer. Nearly 50% of all cancer patients develop a wasting syndrome/process called cachexia at some point in their disease course. The main symptoms of this syndrome include loss of body weight, muscle, fat, and appetite. It is observed very frequently in lung cancer and colorectal cancer patients among other diseases. Cachexia significantly affects patient quality of life and in fact can reduce the time that patients live when compared to patients that have the same stage of disease without cachexia. New work now suggests that ruxolitinib, a drug in a class of oral medications JAK inhibitors, may be able to reduce the loss of body weight, fat, muscle, and appetite that is associated with cancer cachexia patients. Ruxolitinib may also help with improving patient quality of life by reducing the likelihood that a patient has appetite loss or wasting.
Additional locations may be listed on ClinicalTrials.gov for NCT04906746.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To assess toxicity with use of ruxolitinib in non-small cell lung cancer (NSCLC) cachexia patients; to associate levels of JAK/STAT signaling in blood, adipose, and muscle pre- and post-ruxolitinib treatment with changes in cachexia and anorexia.
SECONDARY OBJECTIVES:
I. To describe the adverse events associated with ruxolitinib when administered to cancer cachexia patients.
II. In patients with measurable disease, to describe any preliminary evidence of ruxolitinib’s anti-tumor activity by assessment of objective response as determined by Response Evaluation Criteria in Solid Tumors (RECIST) in cancer cachexia patients.
III. To describe any preliminary evidence suggesting that ruxolitinib improves quality of life (QoL) for cancer cachexia patients.
IV. To describe any preliminary evidence suggesting that ruxolitinib suppresses body weight loss in cancer cachexia patients.
V. To describe any preliminary evidence suggesting that ruxolitinib suppresses adipose and lean muscle loss in cancer cachexia patients.
VI. To describe any preliminary evidence suggesting that ruxolitinib suppresses anorexia in cancer cachexia patients.
VII. To describe any preliminary evidence suggesting that ruxolitinib improves survival in cancer cachexia patients.
EXPLORATORY OBJECTIVES:
I. To assess serum for assessments of changes in circulating cytokine levels, triglycerides, fatty acids, glycerol, etc. that would be suggestive of ruxolitinib suppression of systemic and local inflammation.
II. To assess adipose and muscle biopsies for regulation of JAK/STAT activation by ruxolitinib.
OUTLINE: This is a dose-escalation study.
Patients receive ruxolitinib orally (PO) twice daily (BID) during months 2 and 3 of standard of care (SOC) induction treatment. Treatment repeats every 28 days for up to 2 cycles (i.e., months 2 and 3) in the absence of disease progression or unacceptable toxicity. NOTE: Patients do not receive ruxolitinib during month 1 of SOC induction treatment. Patients also undergo dual x-ray absorptiometry (DEXA) and blood sample collection throughout the study. Additionally, patients undergo adipose and muscle biopsy at screening and optionally throughout the study.
After completion of study treatment, patients are followed for 1 month (i.e., month 4 of SOC induction treatment).
Lead OrganizationUT Southwestern/Simmons Cancer Center-Dallas
Principal InvestigatorTu Dan
