NCT00869388

Brief Summary

This study will evaluate toxicity associated with escalating doses of rBBX-01 given bi-weekly to patients with solid tumors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 15, 2013

Status Verified

July 1, 2013

Enrollment Period

1.1 years

First QC Date

March 25, 2009

Last Update Submit

July 12, 2013

Conditions

Solid Tumors

Keywords

malignantresistantsolid tumor

Outcome Measures

Primary Outcomes (1)

  • To determine the dose limiting toxicity and safety of bi-weekly courses of rBBX-01 in patients with resistant solid tumor malignancies.

    Four bi-weekly 5 day courses

Secondary Outcomes (1)

  • To evaluate the pharmacokinetic and pharmacodynamics of bi-weekly rBBX-01. To correlate the inter-patient sensitivity to rBBX-01 with in vitro studies on patient blood. To describe any anti-tumor activity of rBBX-01.

    4 bi-weekly 5 day courses

Study Arms (4)

Arm 1

EXPERIMENTAL

rBBX-01 1.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7

Biological: rBBX-01

Arm 2

EXPERIMENTAL

rBBX-01 2.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7

Biological: rBBX-01

Arm 3

EXPERIMENTAL

rBBX-01 4.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7

Biological: rBBX-01

Arm 4 (optional)

EXPERIMENTAL

rBBX-01 8.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7

Biological: rBBX-01

Interventions

rBBX-01BIOLOGICAL
Arm 1Arm 2Arm 3Arm 4 (optional)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Confirmed metastatic or unresectable, resistant solid tumor. Gynecologic tumors preferred.
  • years and above
  • GOG performance status greater than or equal to 2
  • Life expectancy greater than 6 months
  • Acceptable organ and marrow function
  • Willingness to agree to use adequate contraception prior to study entry and for the duration of study participation

You may not qualify if:

  • Chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or have not recovered from adverse events due to agents administered more than 4 weeks earlier
  • Not receiving any other investigational agents
  • Known brain metastasis
  • Uncontrolled intercurrent illness including, but not limited to ongoing ore active infection, symptomatic congestive heart failure, unstable angina pectoris,cardiac arrythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnancy
  • Immunosuppression including subjects with known HIV infection on immunosuppressive drugs or having an autoimmune disorder
  • Penicillin allergy
  • Symptomatic prostate hypertrophy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (4)

  • Basche M, Gustafson DL, Holden SN, O'Bryant CL, Gore L, Witta S, Schultz MK, Morrow M, Levin A, Creese BR, Kangas M, Roberts K, Nguyen T, Davis K, Addison RS, Moore JC, Eckhardt SG. A phase I biological and pharmacologic study of the heparanase inhibitor PI-88 in patients with advanced solid tumors. Clin Cancer Res. 2006 Sep 15;12(18):5471-80. doi: 10.1158/1078-0432.CCR-05-2423.

    PMID: 17000682BACKGROUND

  • Hayashi N, Kinoshita H, Yukawa E, Higuchi S. Pharmacokinetic and pharmacodynamic analysis of subcutaneous recombinant human granulocyte colony stimulating factor (lenograstim) administration. J Clin Pharmacol. 1999 Jun;39(6):583-92. doi: 10.1177/00912709922008191.

    PMID: 10354962BACKGROUND

  • Rosenberg B, Juckett DA, Aylsworth CF, Dimitrov NV, Ho SC, Judge JW, Kessel S, Quensen J, Wong KP, Zlatkin I, Zlatkin T. Protein from intestinal Eimeria protozoan stimulates IL-12 release from dendritic cells, exhibits antitumor properties in vivo and is correlated with low intestinal tumorigenicity. Int J Cancer. 2005 May 1;114(5):756-65. doi: 10.1002/ijc.20801.

    PMID: 15609305BACKGROUND

  • Rader JS, Aylsworth CF, Juckett DA, Mutch DG, Powell MA, Lippmann L, Dimitrov NV. Phase I study and preliminary pharmacology of the novel innate immune modulator rBBX-01 in gynecologic cancers. Clin Cancer Res. 2008 May 15;14(10):3089-97. doi: 10.1158/1078-0432.CCR-07-4250.

    PMID: 18483376BACKGROUND

Related Links

Study Officials

  • Premal Thaker, M.D.

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2009

First Posted

March 26, 2009

Study Start

October 1, 2008

Primary Completion

November 1, 2009

Study Completion

December 1, 2009

Last Updated

July 15, 2013

Record last verified: 2013-07

Locations

US(1)