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

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

Study Overview

• Status: Unknown
• Conditions: Multiple Myeloma
• Intervention / Treatment: Drug: Darinaparson

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States
  • California
    • Santa Barbara, California, United States
    • Santa Rosa, California, United States
    • West Hollywood, California, United States
  • Maryland
    • Bethesda, Maryland, United States
  • New York
    • Buffalo, New York, United States
  • North Carolina
    • Charlotte, North Carolina, United States
  • South Dakota
    • Sioux Falls, South Dakota, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: ZIO-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response Rate	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Survival (overall and progression free)	6 months
toxicities	6 months

Collaborators and Investigators

• Sponsor: Alaunos Therapeutics

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: January 16, 2007
• First Submitted That Met QC Criteria: January 17, 2007
• First Posted (Estimate): January 18, 2007

Study Record Updates

• Last Update Posted (Estimate): November 14, 2013
• Last Update Submitted That Met QC Criteria: November 13, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Multiple Myeloma; arsenic; cancer study; failed treatment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: SGL2001b