A Phase II Trial of ZIO-101 in Advanced Multiple Myeloma: Protocol SGL2001b

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ziopharm
ClinicalTrials.gov Identifier:
NCT00423644
First received: January 16, 2007
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

The study of safety of a new organic arsenic compound in the treatment of advanced multiple myeloma


Condition Intervention Phase
Multiple Myeloma
Drug: Darinaparson
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of ZIO-101 in Advanced Multiple Myeloma: Protocol SGL2001b

Resource links provided by NLM:


Further study details as provided by Ziopharm:

Primary Outcome Measures:
  • Response Rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival (overall and progression free) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • toxicities [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: January 2007
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm Drug: Darinaparson
420 mg/m2 of Darinaparsin given twice weekly for three weeks, followed by one week of rest for up to six months
Other Name: ZIO-101

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. Subjects with a confirmed diagnosis of active multiple myeloma with measurable protein criteria present to evaluate response. Measurable disease is defined as having at least one of the following criteria within 28 days prior to registration:

    1. Serum M-protein level > 0.5 gm/dl (10.0 g/L) measured by serum protein electrophoresis.
    2. Urinary M-protein excretion > 0.2 g/24 hours by urine electrophoresis.
  2. Subjects must have relapsed or resistant disease, defined as either relapsing or is resistant after > 2 lines of prior therapy for myeloma. A minimum of 42 days must have elapsed since prior autologous or allogeneic transplant;
  3. Informed consent compliant with ZIOPHARM policies and approved by the Human Investigation Review Committee with jurisdiction over the site;
  4. ECOG performance score ≤ 1;
  5. No chemotherapy, bortezomib, lenalidomide, thalidomide, arsenic trioxide, radiation therapy or immune therapy for ≥ 3 w and recovered from all treatment associated toxicities prior to registration; 5a. Patients may not receive more than the equivalent of 10 mg of prednisone per day for 2 weeks prior to registration.
  6. Age ≥ 18;
  7. Granulocytes ≥ 1.0 x 109/L; platelets ≥ 50 x 109/L;
  8. Bilirubin ≤ 2.0 mg/dL; AST and ALT ≤ 2 x ULN;
  9. Creatinine ≤ 3 X ULN.
  10. No investigational agents within 28 days of study entry.
  11. Males who agree to use a double-barrier method of birth control, (Double barrier method is defined as: a condom and either a diaphragm/cervical cap or an IUD).

Exclusion Criteria

  1. NYHA functional class ≥ 3, myocardial infarction ≤ 6 mo or uncontrolled cardiac arrhythmia other than asymptomatic atrial fibrillation; QTc ≥ 450msec; AV-block ≥ grade-2 or LBBB;
  2. Women of childbearing potential. (Non-childbearing potential is defined as: surgical sterilization or 2 years post-menopausal)
  3. Active infection requiring antibiotics;
  4. Allergy to ZIO-101 or its excipients;
  5. Baseline confusion or dementia, defined as grade > 2 CTCAE Version 3.0;
  6. Significant neurotoxicityneuropathology, defined as grade > 2 neurotoxicity neuropathology per CTCAE Version 3.0;
  7. Prior seizures ≥ grade-3 in CTC v.3 criteria.
  8. Prior history of neurological deficits (e.g., stroke, dementia, ischemia) that has the potential to confound a post-dose neurological assessment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423644

Locations
United States, Arizona
Glendale, Arizona, United States
United States, California
Santa Barbara, California, United States
Santa Rosa, California, United States
West Hollywood, California, United States
United States, Maryland
Bethesda, Maryland, United States
United States, New York
Buffalo, New York, United States
United States, North Carolina
Charlotte, North Carolina, United States
United States, South Dakota
Sioux Falls, South Dakota, United States
Sponsors and Collaborators
Ziopharm
  More Information

No publications provided

Responsible Party: Ziopharm
ClinicalTrials.gov Identifier: NCT00423644     History of Changes
Other Study ID Numbers: SGL2001b
Study First Received: January 16, 2007
Last Updated: November 13, 2013
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Ziopharm:
Multiple Myeloma
arsenic
cancer study
failed treatment

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014