Solid TumorsPhase 1NCT00869388
A Phase I Study of Bi-Weekly rBBX-01 in Patients With Solid Tumors
A Phase 1 study testing rBBX-01 in people with Solid Tumors, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study will evaluate toxicity associated with escalating doses of rBBX-01 given bi-weekly to patients with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors
- What is being tested?
- rBBX-01
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Dec 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed metastatic or unresectable, resistant solid tumor. Gynecologic tumors preferred.
- 18 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
This study will evaluate toxicity associated with escalating doses of rBBX-01 given bi-weekly to patients with solid tumors.
- Conditions
- Solid Tumors
- Being tested
- rBBX-01
- Keywords
- malignant, resistant, solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rBBX-01Biological
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | rBBX-01 1.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7 Receives: Biological: rBBX-01 |
| Arm 2 | Experimental | rBBX-01 2.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7 Receives: Biological: rBBX-01 |
| Arm 3 | Experimental | rBBX-01 4.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7 Receives: 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 Receives: Biological: rBBX-01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the dose limiting toxicity and safety of bi-weekly courses of rBBX-01 in patients with resistant solid tumor malignancies.
Measured: 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.
Measured: 4 bi-weekly 5 day courses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startOct 2008
- Primary completionNov 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Premal Thaker, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869388
- Sponsor's protocol ID
- 08-0961
- Status last verified
- Jul 2013
- First submitted
- 25 Mar 2009
- Last updated
- 15 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17000682Hayashi 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.
PubMed 10354962Rosenberg 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.
PubMed 15609305Rader 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.
PubMed 18483376
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Bi-Weekly rBBX-01 in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00869388
- Acronym / sponsor ID
- 08-0961
- Conditions
- Solid Tumors
- Keywords
- malignant, resistant, solid tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 26 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate toxicity associated with escalating doses of rBBX-01 given bi-weekly to patients with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: rBBX-01rBBX-01 1.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7 |
| Arm 2 | Experimental | Biological: rBBX-01rBBX-01 2.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7 |
| Arm 3 | Experimental | Biological: rBBX-01rBBX-01 4.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7 |
| Arm 4 (optional) | Experimental | Biological: rBBX-01rBBX-01 8.0 mg/m2 SC on 5 consecutive days on weeks 1, 3, 5, and 7 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Confirmed metastatic or unresectable, resistant solid tumor. Gynecologic tumors preferred.
- 18 years and above
- GOG performance status greater than or equal to 2
- Life expectancy greater than 6 months
- Acceptable organ and marrow function
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rBBX-01 | Biological | Arm 1, Arm 2, Arm 3, Arm 4 (optional) |
Primary outcome
To determine the dose limiting toxicity and safety of bi-weekly courses of rBBX-01 in patients with resistant solid tumor malignancies.
Time frame: Four bi-weekly 5 day courses
1 secondary outcome
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.
Time frame: 4 bi-weekly 5 day courses
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2013.
- Background: PubMed 17000682Basche 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.
- Background: PubMed 10354962Hayashi 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.
- Background: PubMed 15609305Rosenberg 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.
- Background: PubMed 18483376Rader 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.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Premal Thaker, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing rBBX-01 in people with Solid Tumors, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the dose limiting toxicity and safety of bi-weekly courses of rBBX-01 in patients with resistant solid tumor malignancies. (time frame: Four bi-weekly 5 day courses). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00869388, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2013.