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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00423644
Recruitment Status : Unknown
Verified November 2013 by Ziopharm.
Recruitment status was:  Active, not recruiting
First Posted : January 18, 2007
Last Update Posted : November 14, 2013
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Multiple Myeloma Drug: Darinaparson Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of ZIO-101 in Advanced Multiple Myeloma: Protocol SGL2001b
Study Start Date : January 2007
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Response Rate [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Survival (overall and progression free) [ Time Frame: 6 months ]
  2. toxicities [ Time Frame: 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00423644

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

Responsible Party: Ziopharm Identifier: NCT00423644     History of Changes
Other Study ID Numbers: SGL2001b
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: November 14, 2013
Last Verified: November 2013

Keywords provided by Ziopharm:
Multiple Myeloma
cancer study
failed treatment

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