Ridaforolimus and Vorinostat in Treating Patients With Advanced Solid Tumors or Lymphoma

Completed · Phase 1

Conditions studied: Lymphoma, Unspecified Adult Solid Tumor, Protocol Specific

In brief

This phase I trial is studying the side effects and best dose of giving ridaforolimus and vorinostat together in treating patients with advanced solid tumors or lymphoma. Giving ridaforolimus in combination with vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.

Key facts

Study ID: NCT01169532
Run by: Fox Chase Cancer Center
People needed: 16
Starts: 2010-10-01
Expected to finish: 2014-03-01
Last updated by the study team: 2021-02-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Histological or cytological confirmation of a solid, malignant tumor or lymphoma that is refractory to standard therapies or for which no standard therapies exist
Patients must have received at least one prior systemic therapy
Measureable disease by RECIST v 1.1
ECOG PS 0 or 1
ANC >= 1500/uL
Hgb >= 9 g/dL
Platelets >= 100,000/uL
AST/SGOT and ALT/SGPT =< 2.5 x upper limit of normal (ULN) or =< 5.0 x ULN in patients with liver metastases
Total Bilirubin =< 1.5 times ULN
Creatinine =< 2.0 mg/dL or Creatinine Clearance (calculated or 24 hour urine) >= 50 ml/min
Female patients of childbearing potential must have a negative serum or urine pregnancy test =< 21 days of study enrollment and agree to use an effective method of contraception for the duration of the study
Ability to understand and willingness to sign written informed consent

You may not qualify if…

Prior anti-cancer treatment with either an mTOR inhibitor (i.e. temsirolimus, everolimus), or an HDAC inhibitor (i.e. Vorinostat)
Patients who have received bevacizumab =< 6 weeks prior to day 1 of study treatment; patients who have received other chemotherapy, immunotherapy, or radiotherapy =< 3 weeks prior to day 1 of study treatment or those who have not recovered from acute adverse events due to agents administered >= 3 weeks earlier; for patients receiving targeted therapy, treatment must be discontinued at least five half-lives prior to initiation of day 1 of study treatment
Patients who have taken valproic acid =< 2 weeks of study enrollment; valproic acid is another HDAC inhibitor
Patients who are pregnant, plan to become pregnant, or are breastfeeding
History of gastrointestinal bleeding within1 month of enrollment
Serum cholesterol >= 350 mg/dL or serum triglycerides >= 400 mg/d
Poorly controlled Type 1 or 2 diabetes, defined as hemoglobin A1C greater than 8% or a fasting glucose of > 160 mg/dL
Active infection requiring antibiotics
Anaphylactic reaction to macrolide antibiotics, Tween 80 (polysorbate 80)
Patients who are not adequately recovered from a prior surgical procedure or major surgical procedure within 2 weeks prior to the first dose of study drug
Myocardial infarction of unstable angina within 3 months of study entry
NY Heart Association class III or IV congestive heart failure
Known active parenchymal brain metastases; patients who have had brain metastases resected, or have received radiation therapy ending > 4 weeks prior to study entry are eligible if they meet all of the following criteria: 1) residual neurologic symptoms < grade 1, 2) no steroid requirement, 3) a follow-up MRI shows regression or stability of lesions after treatment, with no new lesions appearing
Unable to swallow whole pills
A requirement for one of the prohibited medications; if patient is currently taking one of these medications, they may be eligible so long as they discontinue the prohibited medication prior to starting study treatment and remain off for the duration they are taking study treatment
Known diagnosis of HIV
Concurrent malignancies are excluded with the following exceptions: basal cell skin cancer is allowed; cervical carcinoma in situ is allowed; any malignancy that does not require active treatment, and from which the patient has been disease free for >= 3 years is allowed

Where it is running

Fox Chase Cancer Center — Rockledge, Pennsylvania, United States

Full record on ClinicalTrials.gov

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