A Rollover Study for Patients Who Participated in Other Romidepsin Protocols
Condition: Lymphoma; Cancer
Intervention: Romidepsin
Intervention description: The participants will generally continue at the same dose, infusion time and frequency used for the last dose of romidepsin given in the preceding romidepsin study. If the participant entered this rollover study in the middle of a cycle, then the cycle number and cycle day will be carried over from the preceding romidepsin study.
Intervention MeSH terms: Romidepsin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rollover protocol; romidepsin; Gloucester Pharmaceuticals; Celgene Corporation; continuing treatment

Summary:

      This study is intended to provide access to Romidepsin for participants who received
      Romidepsin in other trials sponsored by Gloucester Pharmaceuticals or Celgene Corporation and
      for participants whom the investigator feels may benefit from continuing treatment with
      Romidepsin.
    

Eligibility criteria:

        Inclusion Criteria

          1. Previously participated in and fulfilled the inclusion and exclusion criteria in one
             of the romidepsin clinical trials: ROMI-ADVM-001 (NCT01324310), ROMI-ADVM-002
             (NCT01324323). Additional studies added at the discretion of the medical monitor of
             the study

          2. Physician believes continued romidepsin treatment is of benefit to participant.

          3. Understand and voluntarily sign an informed consent document prior to any study
             related assessments/procedures are conducted.

          4. Able to adhere to the study visit schedule and other protocol requirements.

          5. Negative urine or serum pregnancy test for females of child bearing potential; and

          6. All females of child bearing potential must use an effective method of contraception
             (an intrauterine contraceptive device [IUCD] or double contraceptive method using
             condoms and a diaphragm plus spermicide) during the treatment period and for at least
             1 month thereafter. Male participants should use contraception during the treatment
             period and for at least 3 months thereafter. Female participants should avoid the use
             of estrogen-containing contraceptives, since romidepsin may reduce the effectiveness
             of estrogen-containing contraceptives. An in vitro binding assay determined that
             romidepsin competes with β-estradiol for binding to estrogen receptors.

        Exclusion Criteria

          1. Concomitant use of drugs that may cause a significant prolongation of the corrected
             measurement of the time between the start of cardiac Q wave and the end of the T wave
             (QTc) .

          2. Concomitant use of Cytochrome P 450 3A4 (CYP3A4) strong inhibitors within 1 week of
             trial medications.

          3. Concomitant use of therapeutic warfarin due to a potential drug interaction. Use of a
             low dose of warfarin or another anticoagulant to maintain patency of venous access
             port and cannulas is permitted.

          4. Prior chemotherapy or radiotherapy or any investigational agent after the last dose of
             romidepsin from the preceding romidepsin study.

          5. Participants who are pregnant or breast-feeding.