Kidney CancerPhase 2NCT00003968
Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer
A Phase 2 study testing bryostatin 1 in people with Kidney Cancer, run by National Cancer Institute (NCI) at 17 sites in United States.
Trial summary
Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have metastatic kidney cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- bryostatin 1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 17 sitesUnited States
- Study dates
- Jun 1999to Dec 2003
- Phase
- Phase 2
- 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
DISEASE CHARACTERISTICS:
- Histologically confirmed metastatic renal cell carcinoma
- Bidimensionally measurable disease
- Clear evidence of progression if only site of measurable disease is within previous radiation port
- Previously irradiated brain metastases allowed, if not life threatening, symptoms controlled for 3 months, and not requiring corticosteroids
PATIENT CHARACTERISTICS:
- Age: 18 and over
- Performance status: ECOG 0-1
- Life expectancy: Greater than 3 months
- WBC at least 3,000/mm3
- Platelet count at least 100,00/mm3
- Bilirubin no greater than 1.5 mg/dL
- Creatinine no greater than 2.0 mg/dL OR creatinine clearance greater than 50 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception for 1 month before, during, and for 3 months after study
- No active bacterial or viral infection
- No serious underlying medical condition that would interfere with compliance
- No other malignancy within the past 5 years except basal cell carcinoma of the skin
- No dementia or altered mental status that would prevent informed consent
PRIOR CONCURRENT THERAPY:
- No more than 1 prior therapy with biologic response modifiers
- No prior chemotherapy for advanced disease
- No other concurrent chemotherapy
- No concurrent steriods (except topical use)
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
- At least 4 weeks since major surgery (including nephrectomy)
- No other concurrent experimental agents
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Bon Secours-Holy Family Health System
Altoona, Pennsylvania, 16602
Delaware County Memorial Hospital
Drexel Hill, Pennsylvania, 19026
Hunterdon Regional Cancer Center
Flemington, New Jersey, 08822
Pinnacle Health Hospitals
Harrisburg, Pennsylvania, 17105-8700
Conemaugh Memorial Hospital
Johnstown, Pennsylvania, 15905
Kimball Medical Center
Lakewood, New Jersey, 08701
Saint Mary Medical Center
Langhorne, Pennsylvania, 19047
North Penn Hospital
Lansdale, Pennsylvania, 19446
South Jersey Hospital - Millville
Millville, New Jersey, 08332
Fox Chase Cancer Center at Virtua-Memorial Hospital Burlington County
Mount Holly, New Jersey, 08060
Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Pottstown Memorial Regional Cancer Center
Pottstown, Pennsylvania, 19464
Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
Riverview Medical Center
Red Bank, New Jersey, 07701
Community Medical Center
Toms River, New Jersey, 08755
St. Francis Medical Center
Trenton, New Jersey, 08629
About this study
Official title: Phase II Study of Bryostatin-1 in Metastatic Renal Cell Carcinoma(Summary Last Modified 8/1999)
Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have metastatic kidney cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Read the detailed description
OBJECTIVES:
- Determine the objective response rate to bryostatin 1 in patients with advanced renal cell carcinoma.
II. Assess the toxicities of this treatment regimen in this patient population. III. Determine the time to disease progression in patients receiving this treatment regimen.
IV. Determine the overall survival of this patient population treated with this regimen.
OUTLINE:
Patients receive bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progresssion.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
- Conditions
- Kidney Cancer
- Being tested
- bryostatin 1
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer
- Medical subject headings
- Kidney Neoplasms, Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bryostatin 1Drug
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progresssion. Receives: Drug: bryostatin 1 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2004 (estimated)
- Study startJun 1999
- Primary completionDec 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Naomi S. Balzer-Haas, MD, Study chair, Fox Chase Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003968
- Sponsor's protocol ID
- NCI-2012-02303
- Other IDs
- FCCC-99012, NCI-T99-0002, CDR0000067169
- Status last verified
- Jan 2004
- First submitted
- 1 Nov 1999
- Last updated
- 8 Feb 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Bryostatin-1 in Metastatic Renal Cell Carcinoma(Summary Last Modified 8/1999)
- ClinicalTrials.gov ID
- NCT00003968
- Acronym / sponsor ID
- NCI-2012-02303
- Conditions
- Kidney Cancer
- Keywords
- stage IV renal cell cancer, recurrent renal cell cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- Jun 1999
- Primary completion
- Dec 2003 (actual)
- First posted
- 3 May 2004 (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.
Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have metastatic kidney cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
Detailed description
OBJECTIVES:
- Determine the objective response rate to bryostatin 1 in patients with advanced renal cell carcinoma.
II. Assess the toxicities of this treatment regimen in this patient population. III. Determine the time to disease progression in patients receiving this treatment regimen.
IV. Determine the overall survival of this patient population treated with this regimen.
OUTLINE:
Patients receive bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progresssion.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: bryostatin 1Patients receive bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progresssion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| bryostatin 1 | Drug | Arm I |
Primary outcome
Not reported in the source record.
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 8 Feb 2013.
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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.
Naomi S. Balzer-Haas, MD study chair
Fox Chase Cancer Center
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bryostatin 1 in people with Kidney Cancer, run by National Cancer Institute (NCI) at 17 sites 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?
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 8 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
Where can I read the original study information?
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 8 Feb 2013.