CancerEarly Phase 1NCT00499733
Cyclophosphamide and Cryoablation in Treating Patients With Advanced or Metastatic Epithelial Cancer
A Early Phase 1 study testing cyclophosphamide and Cryoablation in people with Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Cryoablation kills cancer cells by freezing them. Giving chemotherapy together with cryoablation may kill more cancer cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Cancer
- What is being tested?
- cyclophosphamide and Cryoablation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to 9 Jan 2013
- Phase
- Early 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of epithelial solid tumors of any of the following sites or types:
- Lung (closed to accrual as of 4/2/2009)
- Renal
- Prostate
- Breast (closed to accrual as of 4/2/2009)
- Sarcoma (closed to accrual as of 4/2/2009)
- Colon (closed to accrual as of 4/2/2009)
- Liver(closed to accrual as of 4/2/2009)
- Pancreatic (closed to accrual as of 4/2/2009)
- Bone (closed to accrual as of 4/2/2009)
- Head and neck (closed to accrual as of 4/2/2009)
- Melanoma (closed to accrual as of 4/2/2009)
- Carcinoma of unknown primary (closed to accrual as of 4/2/2009)
- Advanced or metastatic disease
- Ineligible for or unwilling to undergo surgical resection
- Eligible for cryotherapy but not expected to be cured by cryotherapy alone
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 3 months
- Creatinine < 2.5 mg/dL
- Platelet count >75,000/mm³
- INR< 1.5
- No known HIV positivity
- No active, uncontrolled infection
- Not pregnant
- Negative pregnancy test
- Women of childbearing potential must practice adequate contraception
- No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site
Brady Urological Institute at Johns Hopkins Hospital
Baltimore, Maryland, 21205
About this study
Official title: Sequential Administration of Cryoablation and Cyclophosphamide for Advanced Solid Epithelial Cancer
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Cryoablation kills cancer cells by freezing them. Giving chemotherapy together with cryoablation may kill more cancer cells.
PURPOSE: This clinical trial is studying how well giving cyclophosphamide together with cryoablation works in treating patients with advanced or metastatic epithelial cancer.
Read the detailed description
OBJECTIVES:
- Document radiologic and/or tumor marker response to cryotherapy of tumor lesions followed by cyclophosphamide.
OUTLINE: This is a pilot study.
Patients undergo percutaneous biopsy of the targeted lesion prior to cryoablation. Patients then undergo percutaneous or open cryotherapy of the largest or most accessible lesion on day 0. On day 3, patients receive cyclophosphamide IV over 1 hour.
Tumor markers (if applicable) are assessed at baseline and monthly during study until marker progression.
After completion of study therapy, patients are followed periodically for up to 3 years.
- Conditions
- Cancer
- Being tested
- cyclophosphamide, Cryoablation
- Keywords
- carcinoma of unknown primary, recurrent carcinoma of unknown primary, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, stage III renal cell cancer, stage IV renal cell cancer, recurrent renal cell cancer, stage III prostate cancer, stage IV prostate cancer, recurrent prostate cancer, male breast cancer, recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer
- Medical subject headings
- Neoplasms, Neoplasms, Unknown Primary, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma, Carcinoma, Renal Cell, Prostatic Neoplasms, Breast Neoplasms, Male, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cyclophosphamideDrug
Also called cytoxan
500 mg/m^2 of cyclophosphamide is infused via intravenous route three days post cryoablation surgery.
CryoablationDevice
Per treating physician's discretion, largest and most accessible lesion will be treated with cryoablation surgery on day 0 of the study.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participant will receive one time intravenous infusion of cyclophosphamide three days after scheduled cryoablation surgery. Receives: Drug: cyclophosphamide; Device: Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity
Measured: Two years
Secondary outcomes (1)
Tumor response, according to RECIST criteria
tumor response will be measured according to RECIST (Response Evaluation Criteria In Solid Tumors) criteria.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2007 (estimated)
- Study startJun 2007
- Primary completionJul 2010
- Study completion9 Jan 2013
Why it stopped: The study was terminated per PI decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ronald Rodriguez, MD, PhD, Principal investigator, Brady Urological Institute at Johns Hopkins Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00499733
- Sponsor's protocol ID
- J0685
- Other IDs
- P30CA006973, NA_00003073, JHOC-J0685, CDR0000554417
- Status last verified
- Feb 2017
- First submitted
- 10 Jul 2007
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Administration of Cryoablation and Cyclophosphamide for Advanced Solid Epithelial Cancer
- ClinicalTrials.gov ID
- NCT00499733
- Acronym / sponsor ID
- J0685
- Conditions
- Cancer
- Keywords
- carcinoma of unknown primary, recurrent carcinoma of unknown primary, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, recurrent non-small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated per PI decision.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2007 (actual)
- Primary completion
- Jul 2010 (actual)
- Study completion
- 9 Jan 2013 (actual)
- First posted
- 11 Jul 2007 (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, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Cryoablation kills cancer cells by freezing them. Giving chemotherapy together with cryoablation may kill more cancer cells.
PURPOSE: This clinical trial is studying how well giving cyclophosphamide together with cryoablation works in treating patients with advanced or metastatic epithelial cancer.
Detailed description
OBJECTIVES:
- Document radiologic and/or tumor marker response to cryotherapy of tumor lesions followed by cyclophosphamide.
OUTLINE: This is a pilot study.
Patients undergo percutaneous biopsy of the targeted lesion prior to cryoablation. Patients then undergo percutaneous or open cryotherapy of the largest or most accessible lesion on day 0. On day 3, patients receive cyclophosphamide IV over 1 hour.
Tumor markers (if applicable) are assessed at baseline and monthly during study until marker progression.
After completion of study therapy, patients are followed periodically for up to 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: cyclophosphamide, Device: CryoablationParticipant will receive one time intravenous infusion of cyclophosphamide three days after scheduled cryoablation surgery. |
Who may qualify
- Ages
- 18 to 120 years
- 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 |
|---|---|---|
| cyclophosphamideAlso: cytoxan500 mg/m^2 of cyclophosphamide is infused via intravenous route three days post cryoablation surgery. | Drug | Intervention |
| CryoablationPer treating physician's discretion, largest and most accessible lesion will be treated with cryoablation surgery on day 0 of the study. | Device | Intervention |
Primary outcome
Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity
Time frame: Two years
1 secondary outcome
Tumor response, according to RECIST criteria
Time frame: Two years
Results and safety
The study was stopped early (reason given: The study was terminated per PI decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Ronald Rodriguez, MD, PhD principal investigator
Brady Urological Institute at Johns Hopkins Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing cyclophosphamide and Cryoablation in people with Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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: stopped early, as of the sponsor's last update on 18 Jan 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: The study was terminated per PI decision.). Results are not available in the source record.
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?
Safety, in terms of absences of severe adverse events (SAE) and unacceptable toxicity (time frame: Two years). It is what the study was designed to measure, not a finding.
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 18 Jan 2019.