Refractory Nasopharyngeal CarcinomaPhase 2NCT00484601
Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma
A Phase 2 study testing Ifosfamide and Doxorubicin in people with Refractory Nasopharyngeal Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in Singapore.
Trial summary
This research is to test the effectiveness and toxicity of both Ifosfamide and Doxorubicin. It also aims to explore the relationship between EBV DNA and clinical response in patients with advanced naso-pharyngeal cancer which has been previously treated with chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Nasopharyngeal Carcinoma
- What is being tested?
- Ifosfamide and Doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSingapore
- Study dates
- 15 Apr 2004to 7 Nov 2007
- 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
Who may be able to join
- Histological diagnosis of NPC
- Age > 18 years old
- Measurable metastatic or recurrent disease (s)
- Received one prior chemotherapy regimen for metastatic or recurrent NPC which relapsed or became refractory before entry.
- ECOG PS 0, 1 or 2
- WBC > 3,500/uL and ANC > 1,500/uL Platelet > 100,000/uL Creatinine - within normal limits SGOT < 3 X UNL Bilirubin < 2.0 mg/dL
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- Ejection fraction > 45% and no history of myocardial infarction or congestive heart failure in the last 6 months. No history of cardiac ventricular arrythmia or ventricle tachycardia, or uncontrolled atrial fibrillation or supraventricular tachycardia with hemodynamic compromising status.
- Random blood glucose level < 250 mg
- Signed informed consent
Who cannot join
- Received more than one prior chemotherapy for metastatic or recurrent disease
- Ejection fraction < 45%
- WBC < 3,500/UL or ANC < 1,500/UL or P/t < 100,000/UL or SCOT> 3 x UNL or Bilirubin > 2.0 mg/dL or Creatinine > UNL
- ECOG PS > 3
- Hx of myocardial infarction within last 6 months
- Random blood glucose level less than or equal 250 mg
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Johns Hopkins Singapore International Medical Center
Singapore, 308433
About this study
Official title: Phase II Study of Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma
This research is to test the effectiveness and toxicity of both Ifosfamide and Doxorubicin. It also aims to explore the relationship between EBV DNA and clinical response in patients with advanced naso-pharyngeal cancer which has been previously treated with chemotherapy.
Read the detailed description
Nasopharyngeal Cancer (NPC) is one of the common cancer in Southeast Asia. In this region NPC is associated with Epstein Barr Virus (EBV) chronic infection with EBV DNA identifiable in almost all the NPC tumors and patient's serum at the time of diagnosis. Chinese, especially cantonese has the highest incidence. Only about 30% of patients presents early disease and has a good treatment outcome (80% cure for stage I disease and 70% for stage II by radiation).
This research is to test the effectiveness and toxicity of both Ifosfamide and Doxorubicin. It also aims to explore the relationship between EBV DNA and clinical response in patients with advanced naso-pharyngeal cancer which has been previously treated with chemotherapy.
Investigators believe EBV infection is necessary to cause NPC and that EBV DNA levels in the blood may directly relate to the total size of the tumor. Because NPC patients in this situation have a poor outlook, we design this study to evaluate the combination of Ifosfamide and doxorubicin for further treatment. While this combination of medicines has been used in many other forms of cancer, it has not been tested in patients with NPC.
- Conditions
- Refractory Nasopharyngeal Carcinoma
- Being tested
- Ifosfamide, Doxorubicin
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IfosfamideDrug
DoxorubicinDrug
| Study group | Role | What they receive |
|---|---|---|
| Ifosfamide and Doxorubicin | Experimental | Single arm treatment with Ifosfamide and Doxorubicinin patients with Refractory Nasopharyngeal Carcinoma Receives: Drug: Ifosfamide; Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the overall response rate and toxicity including complete response rate, response duration, time to treatment failure, and survival of ifosfamide and doxorubicin as the second line chemotherapy for patients with advanced NPC
Prematured termination, data is not analysed.
Measured: May 2008
Secondary outcomes (1)
To correlate EBVDNA titer with clinical response
Prematured termination, data is not analysed.
Measured: May 2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2007 (estimated)
- Study start15 Apr 2004
- Primary completion7 Nov 2007
- Study completion7 Nov 2007
Why it stopped: Low accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Nasopharyngeal CarcinomaStudies 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alex Chang, MD, Principal investigator, Johns Hopkins Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484601
- Sponsor's protocol ID
- JS0327
- Other IDs
- 03-09-11-08
- Status last verified
- Feb 2019
- First submitted
- 8 Jun 2007
- Last updated
- 11 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT00484601
- Acronym / sponsor ID
- JS0327
- Conditions
- Refractory Nasopharyngeal Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Study start
- 15 Apr 2004 (actual)
- Primary completion
- 7 Nov 2007 (actual)
- Study completion
- 7 Nov 2007 (actual)
- First posted
- 11 Jun 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.
This research is to test the effectiveness and toxicity of both Ifosfamide and Doxorubicin. It also aims to explore the relationship between EBV DNA and clinical response in patients with advanced naso-pharyngeal cancer which has been previously treated with chemotherapy.
Detailed description
Nasopharyngeal Cancer (NPC) is one of the common cancer in Southeast Asia. In this region NPC is associated with Epstein Barr Virus (EBV) chronic infection with EBV DNA identifiable in almost all the NPC tumors and patient's serum at the time of diagnosis. Chinese, especially cantonese has the highest incidence. Only about 30% of patients presents early disease and has a good treatment outcome (80% cure for stage I disease and 70% for stage II by radiation).
This research is to test the effectiveness and toxicity of both Ifosfamide and Doxorubicin. It also aims to explore the relationship between EBV DNA and clinical response in patients with advanced naso-pharyngeal cancer which has been previously treated with chemotherapy.
Investigators believe EBV infection is necessary to cause NPC and that EBV DNA levels in the blood may directly relate to the total size of the tumor. Because NPC patients in this situation have a poor outlook, we design this study to evaluate the combination of Ifosfamide and doxorubicin for further treatment. While this combination of medicines has been used in many other forms of cancer, it has not been tested in patients with NPC.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ifosfamide and Doxorubicin | Experimental | Drug: Ifosfamide, Drug: DoxorubicinSingle arm treatment with Ifosfamide and Doxorubicinin patients with Refractory Nasopharyngeal Carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histological diagnosis of NPC
- Age > 18 years old
- Measurable metastatic or recurrent disease (s)
- Received one prior chemotherapy regimen for metastatic or recurrent NPC which relapsed or became refractory before entry.
- ECOG PS 0, 1 or 2
Key exclusion criteria (6 listed)
- Received more than one prior chemotherapy for metastatic or recurrent disease
- Ejection fraction < 45%
- WBC < 3,500/UL or ANC < 1,500/UL or P/t < 100,000/UL or SCOT> 3 x UNL or Bilirubin > 2.0 mg/dL or Creatinine > UNL
- ECOG PS > 3
- Hx of myocardial infarction within last 6 months
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 |
|---|---|---|
| Ifosfamide | Drug | Ifosfamide and Doxorubicin |
| Doxorubicin | Drug | Ifosfamide and Doxorubicin |
Primary outcome
To evaluate the overall response rate and toxicity including complete response rate, response duration, time to treatment failure, and survival of ifosfamide and doxorubicin as the second line chemotherapy for patients with advanced NPC
Time frame: May 2008
Prematured termination, data is not analysed.
1 secondary outcome
To correlate EBVDNA titer with clinical response
Time frame: May 2008
Results and safety
The study was stopped early (reason given: Low accrual.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2019.
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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.
Alex Chang, MD principal investigator
Johns Hopkins Singapore
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 Ifosfamide and Doxorubicin in people with Refractory Nasopharyngeal Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in Singapore.
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 9 inclusion and 6 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: stopped early, as of the sponsor's last update on 11 Feb 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 Singapore. 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 was stopped early (reason given: Low accrual.). 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?
To evaluate the overall response rate and toxicity including complete response rate, response duration, time to treatment failure, and survival of ifosfamide and doxorubicin as the second line chemotherapy for patients with advanced NPC (time frame: May 2008). 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 11 Feb 2019.