Vorinostat With Gemcitabine, Busulfan, and Melphalan With Stem Cell Transplant (SCT) in Relapsed or Refractory Lymphoid Malignancies

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this clinical research study is to find the highest tolerable dose of vorinostat that can be given with gemcitabine, busulfan, and melphalan with a stem cell transplant. Researchers also want to learn about the safety and level of effectiveness of this combination.

Busulfan and melphalan are designed to kill cancer cells by binding to DNA (the genetic material of cells), which may cause cancer cells to die.

Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die. It may help to increase the effect of busulfan and melphalan on cancer cells by not allowing these cells to repair the DNA damage caused by busulfan or melphalan.

Vorinostat is designed to open up the DNA and allow greater access to drugs that bind to DNA, such as gemcitabine, busulfan and melphalan.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Treatments: BB 1101; Busulfan; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Gemcitabine; Lenograstim; Melphalan; Rituximab; Vorinostat

Criteria

Inclusion Criteria:

1. Age 12 to 65 years

2. Patients with primary refractory or recurrent non-Hodgkin's lymphoma (NHL) or HL that do not qualify for treatment protocols of higher priority.

3. Patients with double-hit NHL, in any state of the disease.

4. Patients with peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) in any state of the disease.

5. Angioimmunoblastic T-cell lymphoma (AITL) in any stage of the disease.

6. Adequate renal function, as defined by estimated serum creatinine clearance >/=50 ml/min and/or serum creatinine

7. Adequate hepatic function, as defined by serum glutamate oxaloacetate transaminase (SGOT) and/or serum glutamate pyruvate transaminase (SGPT)normal; serum bilirubin and alkaline phosphatase

8. Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) >/= 50% of expected corrected for hemoglobin.

9. Adequate cardiac function with left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease.

10. Zubrod performance status <2.

11. Negative Beta diffusing capacity of lung for carbon monoxide (HCG) text in a woman with child-bearing potential, defined as not post-menopausal for 12 months or no previous surgical sterilization

Exclusion Criteria:

1. Patients with grade >/= 3 non-hematologic toxicity from previous therapy that has not resolved to

2. Patients with prior whole brain irradiation

3. Patients with active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA >/=10,000 copies/mL, or >/= 2,000 IU/mL).

4. Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology.

5. Active infection requiring parenteral antibiotics

6. HIV infection, unless the patient is receiving effective antiretroviral therapy with undetectable viral load and normal cluster of differentiation 4 (CD4) counts

7. Patients having received radiation therapy in the month prior to enrollment.

8. Patients with a cQT longer than 500 ms