Head and Neck CancerPhase 2NCT00003443
Bryostatin 1 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
A Phase 2 study testing bryostatin 1 in people with Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with metastatic or recurrent head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- bryostatin 1
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Jul 1998to May 2001
- 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 or recurrent squamous cell carcinoma of the oral cavity, lip, hypopharynx, oropharynx, nasopharynx, paranasal sinuses, nasal cavity, nostril, or larynx that is not curable by surgery or radiation therapy Must have one or more measurable indicator lesions Bone metastases, brain metastases, elevated enzyme levels and lesions on radionuclide scans are not acceptable as the sole parameters of measurable disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC greater than 4,000/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Transaminases (SGOT/SGPT) less than 2.5 times upper limit of normal Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: No unstable cardiac rhythm Other: No active infection requiring antibiotics No concurrent medical condition that makes participation in this study medically unsafe No other prior malignancy in the last 2 years except basal or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or metachronous/synchronous epidermoid/squamous cell cancers of the head and neck Not pregnant or nursing Effective contraception required of all fertile patients
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: One prior chemotherapy regimen as part of a locoregional treatment (e.g., induction/concomitant) allowed, either as primary treatment or as therapy for locoregional relapse, if relapse occurred more than 6 months later No other prior chemotherapy Prior chemoprevention agents (e.g., cisretinoic acid or other vitamin analogues) allowed Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy No prior radiotherapy to more than 50% of bone marrow-bearing bones Surgery: See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10021
About this study
Official title: A Phase II Trial of Bryostatin-1 In Patients With Metastatic or Recurrent Squamos Cell Carcinoma of the Head and Neck
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with metastatic or recurrent head and neck cancer.
Read the detailed description
OBJECTIVES: I. Evaluate the antitumor activity of bryostatin 1 in chemotherapy naive patients with metastatic or recurrent head and neck squamous cell carcinoma, not curable with surgery or radiation therapy. II. Evaluate the safety and toxicity of bryostatin 1 when administered in the prescribed schedule in this patient population. III. Assess cyclin dependent kinase 2 activity, protein kinase C activity, and apoptosis measurements in selected patients with tumors accessible for biopsy following bryostatin 1 therapy.
OUTLINE: Patients receive bryostatin 1 IV over 24 hours once weekly for three weeks followed by one week of rest. Treatment is continued every 4 weeks in the absence of unacceptable toxicity or disease progression. Patients with stable disease after two courses may continue treatment or stop treatment at the discretion of the treating physician.
PROJECTED ACCRUAL: There will be 14-25 patients accrued into this study over 1-2 years.
- Conditions
- Head and Neck Cancer
- Being tested
- bryostatin 1
- Keywords
- stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx, stage IV squamous cell carcinoma of the larynx, recurrent squamous cell carcinoma of the larynx, stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity, recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bryostatin 1Drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2004 (estimated)
- Study startJul 1998
- Primary completionMay 2001
- Study completionMay 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- David G. Pfister, MD, Study chair, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003443
- Sponsor's protocol ID
- 98-042
- Other IDs
- CDR0000066471, NCI-T97-0095
- Status last verified
- Jun 2013
- First submitted
- 1 Nov 1999
- Last updated
- 24 Jun 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Bryostatin-1 In Patients With Metastatic or Recurrent Squamos Cell Carcinoma of the Head and Neck
- ClinicalTrials.gov ID
- NCT00003443
- Acronym / sponsor ID
- 98-042
- Conditions
- Head and Neck Cancer
- Keywords
- stage IV squamous cell carcinoma of the lip and oral cavity, recurrent squamous cell carcinoma of the lip and oral cavity, stage IV squamous cell carcinoma of the oropharynx, recurrent squamous cell carcinoma of the oropharynx, stage IV squamous cell carcinoma of the nasopharynx, recurrent squamous cell carcinoma of the nasopharynx, stage IV squamous cell carcinoma of the hypopharynx, recurrent squamous cell carcinoma of the hypopharynx
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 1998
- Primary completion
- May 2001 (actual)
- Study completion
- May 2001 (actual)
- First posted
- 3 Jun 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.
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with metastatic or recurrent head and neck cancer.
Detailed description
OBJECTIVES: I. Evaluate the antitumor activity of bryostatin 1 in chemotherapy naive patients with metastatic or recurrent head and neck squamous cell carcinoma, not curable with surgery or radiation therapy. II. Evaluate the safety and toxicity of bryostatin 1 when administered in the prescribed schedule in this patient population. III. Assess cyclin dependent kinase 2 activity, protein kinase C activity, and apoptosis measurements in selected patients with tumors accessible for biopsy following bryostatin 1 therapy.
OUTLINE: Patients receive bryostatin 1 IV over 24 hours once weekly for three weeks followed by one week of rest. Treatment is continued every 4 weeks in the absence of unacceptable toxicity or disease progression. Patients with stable disease after two courses may continue treatment or stop treatment at the discretion of the treating physician.
PROJECTED ACCRUAL: There will be 14-25 patients accrued into this study over 1-2 years.
Study design
- Primary purpose
- Treatment
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 | – |
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 24 Jun 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.
David G. Pfister, MD study chair
Memorial Sloan Kettering Cancer Center
1 site 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 Head and Neck Cancer, run by Memorial Sloan Kettering Cancer Center 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?
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 24 Jun 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 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 24 Jun 2013.